Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE REGISTRATION WAS HAVING ISSUES. THE SITE WAS WORKING ON L2-S1, WHEN THEY TRIED TO LABEL L3 IN THE OBLIQUE, IT WOULD LABEL L3 IN THE AP, BUT APPEARED TO ACTUALLY BE ON L2. THE SYSTEM GAVE A CROSSVIEW ERROR. THE SURGERY WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPERIENCED AN INCREASE IN BLOOD LOSS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HERNANDEZ, N. S., DIAZ-AGUILAR, L. D., & PHAM, M. H. (2023). SINGLE POSITION L5-S1 LATERAL ALIF WITH SIMULTANEOUS ROBOTIC POSTERIOR FIXATION IS SAFE AND IMPROVES REGIONAL ALIGNMENT AND LORDOSIS DISTRIBUTION INDEX. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1 007/S00586-023-07841-Y. PURPOSE: MINIMALLY INVASIVE SINGLE POSITION LATERAL ALIF AT L5-S1 WITH SIMULTANEOUS ROBOT-ASSISTED POSTERIOR FIXATION HAS TECHNICAL AND ANATOMIC CONSIDERATIONS THAT NEED FURTHER DESCRIPTION. METHODS: THIS IS A RETROSPECTIVE CASE SERIES OF SINGLE POSITION LATERAL ALIF AT L5-S1 WITH ROBOTIC ASSISTED FIXATION. END POINTS INCLUDED RADIOGRAPHIC PARAMETERS, LORDOSIS DISTRIBUTION INDEX (LDI), COMPLICATIONS, PEDICLE SCREW ACCURACY, AND INPATIENT METRICS. RESULTS: THERE WERE 17 PATIENTS WITH MEAN AGE OF 60.5 YEARS. EIGHT PATIENTS UNDERWENT INTERBODY FUSION AT L5-S1, FIVE PATIENTS AT L4-S1, TWO PATIENTS AT L3-S1, AND ONE PATIENT AT L2-S1 IN SINGLE LATERAL POSITION. OPERATIVE TIMES FOR 1-LEVEL AND 2-LEVEL CASES WERE 193 MIN AND 278 MIN, RESPECTIVELY. MEAN EBL WAS 71 CC. MEAN IMPROVEMENTS IN L5-S1 SEGMENTAL LORDOSIS WERE 11.7 ± 4.0°, L1-S1 LORDOSIS OF 4.8 ± 6.4°, SAGITTAL VERTICAL AXIS OF - 0.1 ±1.7 CM°, PELVIC TILT

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. THE SITE WAS OPERATING FROM T12 TO PELVIS AND THE SURGEON BELIEVED THE RIGHT L2 SCREW WAS APPROXIMATELY 2-3 MM MEDIAL FROM THE PLAN. THE SURGEON TOOK THE SCREW OUT AND REPLACED IT FREE HANDED. THEY WERE THEN ABLE TO CONTINUE ON WITH THE SURGERY. THE PATIENT REPORTED SOME NUMBNESS IN THEIR LEG. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THE PATIENT WAS AFFECTED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SITE WERE UNABLE TO COMPLETE THE REGISTRATION OF THE PATIENT FROM L3 TO S1. THE SITE WERE WORKING WITH A PRE-OP CT SCAN AND PLACED TWO TITANIUM CAGES FROM L4 TO L5 AND L5 TO S1. THEY HAD ALSO PLACED A PELVIC BOLT IN S2. THE MANUFACTURER REPRESENTATIVE SAID THAT THE PELVIC BOLT WAS COVERING THE S1 BODY IN THE OBLIQUE SHOT, BUT DID NOT THINK THE INABILITY TO PERFORM THE REGISTRATION WAS DUE TO THE PELVIC BOLT, BUT THOUGHT THE TITANIUM CAGES MAY HAVE BEEN THE ROOT CAUSE OF THE ISSUE. THE GUIDANCE SYSTEM WAS ABORTED, AS THE SURGEON RESORTED TO THE NAVIGATION SYSTEM. THE DELAY WAS 1 HOUR. THE PATIENT'S BLOOD LOSS WAS INCREASED AND THE PATIENT NEEDED SEVERAL BLOOD TRANSFUSIONS BECAUSE OF THE DELAY. PATIENTS RECOVERY MAY BE AFFECTED, BUT THEIR OUTCOME WILL BE THE SAME.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T. AKAZAWA, Y. TORII, J. UENO ET AL., SAFETY OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY: EXPERIENCE FROM THE INITIAL 125 CASES, JOURNAL OF ORTHOPAEDIC SCIENCE, HTTPS://DOI.ORG/10.1016/J.JOS.2023.06.003 SUMMARY: THE PRESENT STUDY AIMED TO EVALUATE THE SAFETY OF ROBOT-ASSISTED SCREW PLACEMENT IN 125 CASES AFTER INTRODUCING A SPINAL ROBOTICS SYSTEM AND TO IDENTIFY THE SITUATIONS WHERE DEVIATION WAS LIKELY TO OCCUR. THE SUBJECTS WERE 125 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED SCREW PLACEMENT USING A SPINAL ROBOTICS SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC) FROM APRIL 2021 TO JANUARY 2023. THE 1048 SCREWS PLACED WITH ROBOTIC ASSISTANCE WERE EVALUATED. WE INVESTIGATED INTRAOPERATIVE ADVERSE EVENTS OF THE ROBOTICS SYSTEM AND COMPLICATIONS OCCURRING WITHIN 30 DAYS AFTER SURGERY. WE EVALUATED SCREW ACCURACY AND DEVIATION AND COMPARED THEM FOR VERTEBRAL LEVELS, SCREW INSERTION METHODS (OPEN TRADITIONAL PEDICLE SCREW [OPEN-PS], CORTICAL BONE TRAJECTORY SCREW [CBT], PERCUTANEOUS PEDICLE SCREW [PPS], AND S2 ALAR ILIAC SCREW [S2AIS]), DIAGNOSIS, AND PHASES OF SURGICAL CASES. THE DEVIATION RATE OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY WAS 2.2%. COMPLICATIONS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS DONE ACCORDING TO PLAN, BUT AFTER WHEN THE SURGEON CHECKED A POST OPERATIVE CT, ONE SCREW WAS MISPLACED. AFTER THE SURGERY THE PATIENT HAD NEUROLOGICAL DEFICIT. THE PATIENT HAD ISSUES WALKING. THE PROCEDURE WAS NOT DELAYED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE FOUR RIGHT SIDE SCREWS WERE ALL PLACED. THE SYSTEM WAS BROUGHT TO LEFT T1. THE PILOT HOLE WAS DRILLED AND IMMEDIATELY THE PATIENT JOLTED. THE NEUROMONITORING SHOWED SIGNIFICANT REDUCTION IN LEFT LEG SIGNAL. AN ACCURACY CHECK WAS PERFORMED AND INACCURACY WAS NOTED. A NEW SCAN WAS PERFORMED FOLLOWED BY SNAPSHOT. THE SCAN WAS REVIEWED AND POSITION OF ALL RIGHT SIDE SCREWS WAS GOOD. T1 WAS THEN TEMPORARILY OMITTED, AND T2 AND T4 WERE INSTRUMENTED WITHOUT INCIDENT. DURING USE OF THE DRILL FOR T5, AGAIN THE PATIENT JOLTED, WITH THE NEUROMONITORING SHOWING CONSISTENT LOSS IN MOTORS. THE SURGEONS PERFORMED AN ACCURACY CHECK AND WERE HAPPY TO PROCEED. T5 WAS THEN INSTRUMENTED. T1 WAS THEN PREPARED WITH THE DRILL AND THE TAP, WITH THE PLAN OF FREEHAND INSERTION OF THE SCREW INTO THE PREPARED PEDICLE FOLLOWING LAMINECTOMIES AT T1 AND T3. THE NAVIGATION LOOKED ACCURATE AND THE NEUROMONITORING SHOWED NO FURTHER SIGNAL CHANGES. FOLLOWING THE LAMINECTOMIES AND INSERTION OF THE FINAL LEFT T1 SCREW, A FINAL IMAGING SYSTEM SCAN WAS PERFORMED AND SHOWED THAT THE LEFT T5 AND LEFT T

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER INSERTION OF THE PEDICLE SCREWS, IT WAS CONFIRMED THAT T9 LEFT, T5 RIGHT, AND T6 RIGHT WERE DEVIATED FROM THE SPINAL CANAL. THE DEVIATION WAS APPROXIMATELY 3 TO 4MM. THE SCREWS WERE REMOVED. THE PATIENT EXPERIENCED PARALYSIS OF THE RIGHT LOWER LIMB. THE PARALYSIS WAS NOT TRANSIENT. THE PHYSICIAN FELT THAT THE SYMPTOMS WOULD RECOVER TO A CERTAIN EXTENT, BUT WILL NOT COMPLETELY RECOVER. THE CASE WAS COMPLETED WITH FREE HAND. THE SURGEON FELT THAT THE PARALYSIS WAS A RESULT OF THE MALFUNCTION AND THE GUIDANCE SYSTEM. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREW PLACED IN L2 RIGHT WAS LATERAL AND LOW. THIS WAS THE LAST SCREW PLACED, AND SOFT TISSUE PRESSURE OCCURRED. THE SITE WAS UNABLE TO GET THE CANNULA IN, SO THE SURGEON HAD TO ADJUSTED THE TRAJECTORY TO HAVE MORE OF A SKIVE POTENTIAL. THE SCREW DID NOT GO INTO THE HOLE MADE WITH THE DRILL. IT WAS HARD TO REMOVE THE SCREWDRIVER, AND WHEN PULLED OUT THE ARM STATED IT WAS OFF TRAJECTORY. THE SURGEON MOVED FORWARD, AND THE FINAL X-RAY CONFIRMED THE FINAL SCREW WAS OFF. PATIENT COMPLAINT CAME FORWARD. A REVISION SURGERY IS NEEDED IN THE FUTURE. THE PROCEDURE WAS DELAYED BY LESS THAN AN HOUR. THE PATIENT EXPERIENCED LEG PAIN. THE DEVIATION WAS LESS THAN 3.5 MM. THE GUIDANCE SYSTEM WAS ACCURATE, BUT THE SCREW SKIVED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PROCEDURE TO ADDRESS THEIR LUMBAR SPINE, AS THEY WERE EXPERIENCING PAIN AND SYMPTOMS RADIATING INTO THE LEFT HIP, GROIN, AND BUTTOCKS. DURING THE PROCEDURE, AFTER SCREWS WERE PLACED, AND PRIOR TO DECOMPRESSION, THE PATIENT LOST VIRTUALLY ALL MOTOR FUNCTION OF HER RIGHT LOWER EXTREMITY AND IN OTHER NERVE DISTRIBUTIONS. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ADDRESSING THE LOSS IN MOTOR FUNCTION, AND THE PHYSICIAN INDICATED THE CASE WAS COMPLETED WITHOUT COMPLICATION. POST-OPERATIVELY, THE PATIENT REPORTED THAT THEY WERE UNABLE TO MOVE THEIR RIGHT LOWER EXTREMITY. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY, WITH NO INDICATION OF US OF THE GUIDANCE SYSTEM, TO REMOVE OLD HARDWARE THAT WAS PRESENT PRIOR TO THE INITIAL PROCEDURE. THE PHYSICIAN PERFORMED A REVISION OF THEIR DECOMPRESSION, AND NOTED A LARGE DURAL DEFECT ON THE RIGHT, WHICH WAS REPAIRED THROUGH THE USE OF SUTURES, A TACHOSIL PATCH, AND SURGICAL GLUE. THE SURGEON DOCUMENTED THAT THE REMOVAL OF THE OLD HARDWARE CREATED THE DURAL DEFECT AND FLUID LEAK. AFTER THE SECO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY DURING A CASE. THE SCOPE OF THE CASE WAS FROM T5 TO T10, BUT T7 WAS SKIPPED. THE PATIENT WAS IN A PRIOR EVENT THAT CAUSED A COMPLETE SPINAL SEPARATION AT T7 CAUSING THE PATIENT TO BE PERMANENTLY PARALYZED. THE SURGEON HAS STATED THAT THERE WAS NOTHING THAT COULD HAVE BEEN DONE TO RECOVER THE PATIENT'S CURRENT SPINAL STATE. THE CASE WAS A SCAN AND PLAN PROCEDURE. THE SURGEON PLACED ALL THE SCREWS ON THE RIGHT AND LEFT SIDES FROM T5 TO T10 AND WAS ABOUT TO CONFIRM PLACEMENT. HOWEVER, AFTER TAKING THE AP SCOUT SHOT, THE SURGEON IMMEDIATELY DETERMINED THAT ALL OF THE SCREWS WERE NOT ACCORDING TO PLAN. ALL LEFT SCREWS WERE LATERAL AND THE RIGHT SCREWS WERE MEDIAL. SOME WERE WORSE THAN OTHERS. THE SURGEON ONLY USED THE AP SHOT TO DETERMINE THAT THE SCREWS WERE OFF. THE MANUFACTURER REPRESENTATIVE STATED THAT SOME SCREWS WENT STRAIGHT INTO THE SPINAL CORD CANAL. THE REPRESENTATIVE FELT THAT THEY HAD KEPT CLOSE ATTENTION TO THE ENTIRE CASE AND THAT EVERYTHING WAS PERFECT. THE SURGEON DECIDED TO REPLACE ALL SCREWS USING NAVIGATION. ONCE THEY C

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED LESS THAN 3.5MM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED INTRA-OPERATIVELY. IT WAS REPORTED THAT DURING A CASE THE L2-S1 ON THE LEFT AND THOSE SCREWS WERE PLACED FINE. RIGHT L2 WAS MEDIAL WHEN THEY DRILLED AND NOTICED CSF. THEY SPUN L1-T10 AND PROCEED TO DO THOSE WITH THE GUIDANCE SYSTEM. THE SURGEON WENT BACK TO DO L2-S1 WITH THE C-ARM. THERE WAS A DELAY OF LESS THAN 1 HOUR. THE PATIENT DID NOT EXPERIENCE ANY SYMPYOMS DUE TO THE CSF LEAK. THE CAUSE OR SUSPECTED CAUSE OF THE DEVIATION WAS STATED TO BE DUE TO SKIVING. TRAJECTORIES WERE DEVIATED LESS THAN 3.5 MM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY DURING THE SCAN & PLAN CASE. THEY PLANNED THE SCREWS, TAPPED ALL TRAJECTORIES, DRILLED THE PILOT HOLES, AND INSERTED THE SCREWS. THE SURGEON STATED THAT EVERYTHING FELT GOOD DURING THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE SAID THE IMAGES INDICATED LATERAL ON THE LEFT SIDE AND MEDIAL ON THE RIGHT. THE SCOPE OF THE SURGERY WAS FOUR TRAJECTORIES ON L4 AND L5. ALL FOUR TRAJECTORIES LOOKED OFF POST-OP. DELAY WAS APPROXIMATELY 30 MINUTES. THERE WAS NO REPORTED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THE FOOT OR TOES. THE NUMBNESS WAS NOT TEMPORARY. NUMBNESS IS IN THE RIGHT FOOT. THE SURGEON DECIDED TO REVISE RIGHT SIDE L4-5 PEDICLE SCREWS. HE REMOVED AND REPLACED THEM PERCUTANEOUSLY WITH FLUOROSCOPY ON (B)(6) 2023. AT THE TIME OF THE ORIGINAL CASE THE TRAJECTORIES WERE DEVIATED APPROXIMATELY 7MM LOW AND LEFT OF THE PLANNED TRAJECTORIES.

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS SETTING UP FOR A CASE WHEN THE PATIENT PASSED AWAY WHILE THE SURGEON WAS DOING THE INTERBODY PLACEMENT PORTION OF THE PROCEDURE. THE REPRESENTATIVE HAD TURNED THE SYSTEM ON AND ENTERED THE KIT CODE IN PREPARATION FOR ITS USE. THE SYSTEM WAS NOT MOUNTED TO THE BED. NO MEDTRONIC HARDWARE OR EQUIPMENT WAS USED PRIOR TO THE PATIENT PASSING AWAY. THE PROCEDURE WAS NO DELAYED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT THERE WAS NO EFFECT TO THE PATIENT AS THEY COMPLETED THE CASE AND REPORTED THE COMPLAINT THE DAY OF THE SURGERY. THE PATIENT DID NOT EXHIBIT ISSUES UNTIL LATER IN POST-OP.THE PATIENT WAS HAVING WEAKNESS IN ONE LEG WITH SOME DIFFICULTY WALKING. AT THE TIME OF THE CASE NEUROMONITORING WAS SHOWING GOOD SIGNALS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SECOND TO LAST TRAJECTORY WHERE THEY NOTICED THE SCREW SKIVED MEDIALLY. THE SITE TRIED TO SEND TO RIGHT L5, BUT IT WAS NOT ON TRAJECTORY. THE SITE LOST SIGNAL IN THE RIGHT TIBIALIS ANTERIOR NERVE. THE PROCEDURE WAS DELAYED BY THREE TO FIVE MINUTES. THE LAST TWO SCREWS WERE COMPLETED FREEHAND. RIGHT L4 AND L5 WERE BOTH INACCURATE. THE SURGEON ESTIMATED THE DEVIATION TO BE BETWEEN 4-5MM. IT WAS THE LATERAL EDGE OF THE DRILL BIT THAT COMPLETELY BREACHED THE MEDIAL WALL.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS MISPLACED SCREWS AFTER LOOKING AT THE X-RAYS. S1 WAS MISPLACED AND LEFT OUT. THE PATIENT WAS HAVING NUMBNESS AND SOME LOSS OF MOBILITY IN ONE LEG/FOOT. S1 LEFT WAS THE SCREW DEVIATED LATERALLY. THE DEVIATION WAS GREATER THAN 10MM. THE SURGEON WAS NOT USING BOTH HANDS WHEN PLACING THE SCREWS WITH THE DRILL. THE SUSPECTED CAUSE OF THE DEVIATION WAS EXCESSIVE FORCE FROM THE SOFT TISSUE. A REVISION SURGERY HAD TO BE PERFORMED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. THE SURGEON DID NOT SPECIFICALLY STATE THAT THE ISSUE WAS BECAUSE OF THE GUIDANCE SYSTEM, AND HE DID STATE THAT HE WASN'T CERTAIN WHAT HAD HAPPENED. THE CASE WAS AN L2 TO L4 CASE, WHERE THE SIXTH AND LAST SCREW EXPERIENCED DIFFICULTIES. USING A MIDAS DRILL, THE SURGEON DRILLED AS EXPECTED TO PREPARE FOR THE INSERTION OF THE SIXTH SCREW. HOWEVER, WHEN HE PULLED THE DRILL OUT, HE NOTICED EXCESS BLEEDING. TO GET THE BLEEDING UNDER CONTROL, THE SURGEON EXPOSED MORE OF THE PATIENT'S SPINE AND VISUALLY SAW THAT THE MIDAS HAD NICKED THE PATIENT'S SPINAL CORD. NEURO-MONITORING SHOWED THAT THERE WAS DAMAGE DONE TO THE VASTUS MOTORS. AFTER THE SURGEON GOT THE BLEEDING UNDER CONTROL, HE DECIDED TO FREEHAND THE INSERTION OF THE LAST SCREW TO COMPLETE THE SURGERY. THIS EVENT CAUSED A 30 MINUTE DELAY TO THE CASE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TRAJECTORY WAS DEVIATED APPROXIMATELY 4MM FROM THE PLAN. THE TRAJECTORY THAT WAS BREACHED WITH THE MIDAS WAS THE RIGHT L2. THAT WAS THE LAST SCREW BEING PLACED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT TOWARD THE END OF LAST CALENDAR YEAR THERE WERE SOME PATIENT DOCUMENTED WITH POST-OPERATIVE NEUROLOGICAL DEFICITS. ONE OF THE PATIENTS HAD THE DEFICIT REPORTED BY NEUROMONITORING. THE DEFICIT WAS NOTED BY NEUROMONITORING AFTER THE SURGEON HAD EXPANDED THE CAGE AND DETACHED IT FROM THE INSERTER AND WAS BACKFILLING THE CAGE USING THE FUNNEL AND TAP THAT ATTACH TO THE INSERTER. THE SURGEON SLAMMED THE FUNNEL DOWN FAIRLY FORCEFULLY RIGHT BEFORE THE NEUROMONITORING REPRESENTATIVE SPOKE UP REGARDING A DEFICIT. IT WAS BELIEVED THAT THIS OCCURRED TO THREE PATIENTS. THE SYSTEM WAS FUNCTIONING AS INTENDED, AND CAUSE ANY INJURY OR DELAY DURING THE SURGERIES. THE SURGEON BELIEVES THAT THE CAGE POSSIBLY DISTRACTED THE DISC SPACE TOO MUCH AND SOMEHOW PUT STRAIN ON THE SPINAL CORD OR NERVE ROOTS. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT THE DEFICITS WERE CAUSED BY THE CAGES BEING POSTERIOR AND WHEN DETACHING THE CAGE TO POST-PACK IT WITH THE BONE GRAFT, THE CONNECTION OF THE CAGE MAY HAVE BEEN IN A DANGEROUS POSITION IF IT WAS NOT AS ANTERIOR AS IT APPEARED ON NAVIGATION. TH

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T8 L2 CASE WITH A SOLERA VOYAGER, THE GUIDANCE SYSTEM WAS ATTACHED USING MIST BRIDGE WITH TWO PINS IN T10 AND T12. TWO CT TO FLUORO REGISTRATION WERE DONE. ONE FOR T8 AND T9 AND ONE FOR L1 AND L2. AT THE END OF THE SURGERY, ALL THE SCREWS WERE DEVIATED TO THE RIGHT, CAUSING BREACH IN THE CANAL. T8 WAS PATHOGEN AS THE CANAL BREACH CREATED AN OEDEMA. THE PATIENT WAS IMPACTED AND UNDER SURVEILLANCE WITH LEFT LEG PARALYSIS SYMPTOM. THE PATIENT HAD A HIGH BMI, THE TABLE WAS SLIGHTLY TILTED TO THE LEFT AT THE BEGINNING OF THE CASE BEFORE CONNECTING THE MIST BRIDGE TO THE GUIDANCE SYSTEM BUT NO PATIENT MOVEMENT WAS DETECTED DURING THE CASE AND DURING THE TWO REGISTRATIONS. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVIATION WAS BETWEEN 3.5 AND 10 MM.

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ACCURACY ISSUE AT LEFT L5. THE PATIENT EXPERIENCED LEFT FOOT DROP. THE PROCEDURE WAS DELAYED AN HOUR. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE FOOT DROP WAS NOT TEMPORARY AND WAS NOT RESOLVED. THE DEVIATION WAS FIVE TO TEN MILLIMETERS INFERIOR FROM THE PEDICLE AND PLANNED TRAJECTORY. THE SUSPECTED OR MOST LIKELY CAUSE WAS THAT THE L5 ROBOTIC REGISTRATION WAS NOT ACCURATE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS INACCURACY DUE TO A PATIENT SHIFT. ALL THE SCREWS WERE PLACED INACCURATE. ALL SCREWS WERE SHIFTED, SOME MEDIAL AND SOME LATERAL, BUT OVERALL THERE WAS UNIFORM INACCURACY. THE INACCURACY WAS 3.5MM AND LESS. THE FIRST SCREW INSERTED WAS PERFECT. THE SECOND SCREW PLACED WAS OBSTRUCTED BY THE CLAMP. THE NEW TRAJECTORY WAS OBTAINED WITH THE SOFTWARE, THE ARM WAS REPOSITIONED, AND THE ARM WAS UNOBSTRUCTED BY THE CLAMP. AT THIS TIME THE SITE FELT THAT THERE MUST HAVE BEEN PATIENT MOVEMENT THAT WENT UNDETECTED. ALL REMAINING SCREWS ON THE RIGHT SIDE WERE PLACED. TWO OR THREE SCREWS PUNCTURED THE DURA ON THE RIGHT SIDE. THERE WERE ALSO SCREWS THAT WERE PLACED IN THE DISC SPACE. THE LEFT SIDE SCREWS WERE IN THE CANAL. A REVISION SURGERY WAS PERFORMED TO CORRECT THE INACCURACY. THE PATIENT EXPERIENCED LEG PAIN AND THE PROCEDURE WAS DELAYED BY LESS THAN AN HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A SURGICAL DEVIATION THAT OCCURRED ON (B)(6) 2022. THE ORIGINAL PLAN INCLUDED FOUR SCREW INSERTIONS; HOWEVER, ONLY ONE SCREW WAS INSERTED USING THE GUIDANCE SYSTEM. THE USE OF THE GUIDANCE SYSTEM WAS CANCELED AFTER THE DEVIATION WITH THE FIRST SCREW. THE PLAN ANGLE WAS TOO CONVERGENT, SO THE ANATOMY HAD TO BE MOVED SO THE SCREW COULD FIT THROUGH THE INCISION. ONCE THE SCREW MADE CONTACT, THE PATIENT JUMPED, CAUSING A DEVIATION. THE DOCTOR STATED THAT HE PULLED TOO HARD ON THE RETRACTOR, WHICH CAUSED THE SPINE TO SHIFT OVER. THE SURGEON DECIDED THAT A REPAIR NEEDED TO OCCUR ON THE FIRST SCREW INSERTION. A FOLLOW-UP SURGERY OCCURRED ON (B)(6) 2022 WITHOUT THE USE OF THE GUIDANCE SYSTEM USE. THE SURGEON REPORTED THAT THE PATIENT'S MOTOR FUNCTIONS ON HIS LEGS WERE DECREASED DUE TO THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE LESS THAN 3.5MM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: THE AIM OF THIS STUDY WAS TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN A ROBOT-ASSISTED VERSUS A NAVIGATED TRANS PEDICULAR FUSION TECHNIQUE. THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WHO UNDERWENT TRANSPEDICULAR POSTERIOR FUSION OF THE SPINE DUE TO TRAUMA, PYOGENIC SPONDYLODISCITIS AND OSTEOPOROSIS. SURGERY WAS DONE EITHER WITH A ROBOT-ASSISTED OR A PERCUTANEOUS NAVIGATED TRANSPEDICULAR FUSION TECHNIQUE. THE OUTCOME ANALYSIS INCLUDED THE DURATION OF SURGERY, THE RADIATION EXPOSURE, THE POSTOPERATIVE SCREW POSITION AND COMPLICATIONS. A TOTAL OF 60 PATIENTS WERE OPERATED AND 491 SCREWS WERE ANALYSED. NO STATISTICAL DIFFERENCE WAS SEEN IN THE APPLIED CUMULATIVE EFFECTIVE RADIATION DOSE PER PATIENT. THE RADIOLOGICAL ASSESSMENT REVEALED A MORE ACCURATE SCREW PLACEMENT WITH ROBOT ASSISTANCE. A LEARNING CURVE COULD BE OBSERVED IN ROBOT-ASSISTED FUSION. ROBOT-ASSISTED AND NAVIGATED TRANSPEDICULAR FUSION TECHNIQUES ARE BOTH EFFECTIVE AND SAFE. ROBOT-ASSISTED TRANSPEDICULAR SPINE FUSION GOES ALONG WITH HIGHER PLACEMENT ACCURACY BUT ITS IMPLEMENTATION NEEDS AN ADEQUATE LEARNING CURVE. REPORTED EVENT: 5/60 PATIENTS HAD TO UNDERGO REVISION SURGERY AFTER TRANSPE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT SCREWS WERE DEVIATED FROM THE PLAN. THE CALL DROPPED BEFORE MORE INFORMATION WAS RECEIVED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. A TWO LEVEL ALIF WITH PERCUTAENOUS SCREWS AT L3-L5 AND REMOVAL/REVISION OF POSTERIOR SCREWS AT L5-S1 PROCEDURE WAS BEING COMPLETED. THERE ABOUT AN HOUR ADDED TO THE CASE. THE PATIENT EXPERIENCED RIGHT SIDED PAIN POST-OPERATIVELY. THE PATIENT WILL BE GOING BACK FOR A SECOND PROCEDURE TO REVISE SCREWS. AT THE TIME THE SCREWS WERE REVISED FREEHANDED. THE CAUSE OR SUSPECTED CAUSE OF THE DEVIATION WAS SUSPECTED TP BE DUE TO ROTATING THE BED CAUSING A PATIENT SHIFT. TRAJECTORIES WERE DEVIATED ABOUT 4MM. THE SCREWS WERE OUT OF THE PEDICLE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T10 TO PELVIS, T10 ON THE LEFT SEEMED TO BE GROSSLY MEDIAL. THE DOCTOR SENT THE ARM TO THE RIGHT SIDE AND ALL OF THE TRAJECTORIES WERE PERFECT. HE SENT IT BACK TO THE LEFT AND IT STILL LOOKED MEDIAL. HE DRILLED A HOLE AND THE PATIENT BUCKED AND CSF APPEARED. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT THERE WAS A DEVIATION. DURING THE CASE, TWO DIFFERENT REGISTRATIONS WERE TAKEN FOR C7-L1 TO T3-T6. THE SURGEON FINISHED INSERTING ALL THE SCREW ON THE LEFT SIDE OF THE PATIENT, WHEN MOVING TO THE RIGHT AT T4, WHEN USING THE MIDAS DRILL, THE PATIENT SPINAL CORD WAS KNICKED, RESULTING IN LOSS OF MOTOR ON THE RIGHT SIDE OF THE PATIENT. THE MANUFACTURER REPRESENTATIVE NOTED THAT DURING PLANNING, THE SCREW WAS PLANNED A BIT LATERAL TO THE PEDICLE, WHICH COULD CONTRIBUTE TO THE SITUATION. THE SURGEON ENDED UP REMOVING ALL SCREWS AND CLOSE THE PATIENT UP FOR MRI. THE PATIENT WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED ABOUT 3.5MM MEDIALLY. THE SURGERY HAS NOT BEEN RESCHEDULED AS OF YET. THE SITE IS CURRENTLY MONITORING THE PATIENT¿S MOTOR FUNCTION AND WILL RESCHEDULE ONCE EVERYTHING IS BACK TO BASELINE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER AN L2/L3 INTERBODY INSERTION, DURING A L2/-L4 SCREW REVISION AND TLIF SPINAL FUSION, THE SURGEON USED THE GUIDANCE SYSTEM TO INSERT THE FIRST SCREW AT L2 ON THE LEFT. THE PROCEDURE WENT FINE. THE SURGEON THEN USED THE GUIDANCE SYSTEM AGAIN TO PLACE ANOTHER SCREW ON THE RIGHT L2 (SURGEON WAS ON THE PATIENT'S LEFT, DEVIATING FROM STANDARD SITE'S PROCESS), THE PATIENT BUCKED DURING INSERTION. THE SURGEON WAS INFORMED THAT THE PATIENT BUCKED AND DECIDED TO CONTINUE WITH THE CASE. POST-OPERATIVELY THE PATIENT'S RIGHT FOOT HAD SOME SENSATION AND WAS UNABLE TO MOVE. THE SURGEON THEN WENT INTO THE OPERATING ROOM TO REMOVE THE RIGHT L2 SCREW, BUT THE PATIENT'S RIGHT FOOT WAS STILL UNABLE TO MOVE. A POST-OP CT WAS COMPLETED AND REVEALED THAT L2 SCREW WAS MEDIAL.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SYSTEM APPEARED TO REGISTER BUT ACCURACY SEEMED TO BE OFF SIGNIFICANTLY RESULTING IN MISPLACED SCREWS. AT THE TIME OF THE COMPLAINT COMING IN, THE CONFIRMATION SPIN HAD NOT YET BEEN TAKEN, SO EXACT DETAILS OF PLACEMENT WERE NOT YET KNOWN, LIKELY MEDIAL ON THE LEFT AND LATERAL ON THE RIGHT. THE PROCEDURE WAS ON L4-L5, PLACED RIGHT FIRST THEN LEFT, USING CT TO FLUORO WORKFLOW. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS ASSUMED THAT THE TRAJECTORIES WERE OFF GREATER THAN10MM BECAUSE TWO WERE NOT IN BONE. THE SCREWS WERE REMOVED PRIOR TO THE CONFIRMATION SPIN. TWO OF THESE SCREWS PATHWAYS WERE NOT ABLE TO BE LOCATED. NO SCREWS WERE REPLACED AT THE TIME OF THE CASE. THE CASE WAS NOT COMPLETED. THE SCREWS WERE TAKEN OUT AND THE CASE WAS ABORTED. THERE HAS BEEN NO NOTIFICATION ON RESCHEDULING THE CASE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE ARM SEEMED TO SHIFT AFTER THE SITE DRILLED, TAPPED, AND TOOK THE CANNULA OUT. THE ARM LOOKED LIKE IT SHIFTED BY ABOUT 5 MM. WHEN THE SCREW WAS BEING PLACED, IT LOOKED LIKE IT WAS NOT FOLLOWING THE SAME TRACK AND WAS NOT FOLLOWING THE SAME HOLE. THE FIRST SCREW LOOKED MEDIAL ON CONFIRMATION SHOTS. THE SHIFT WAS DURING THE LEFT S1 SCREW PLACEMENT. THE MANUFACTURER REPRESENTATIVE AND HEALTHCARE PROFESSIONALS CAME TO A CONCLUSION THAT THE CANNULA WAS RESTING ON THE L5 SCREW HEAD CAUSING THE ARM TO BE DEVIATED WHEN PLACING THE CANNULA. WHEN THE CANNULA WAS REMOVED THE ARM SHIFTED, AND THE SCREW WAS NOT FALLING INTO THE DRILLED HOLE. THE SURGERY WAS ABORTED AND RESCHEDULED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT MULTIPLE CONTROLLER ERROR MESSAGES WERE OBSERVED. "ERROR 3489 NO CONNECTION DUE TO CONTROLLER ERROR" APPEARED RIGHT AFTER THE SYSTEM WAS MOUNTED TO THE BED. A SOFT REBOOT DID NOT CLEAR THE ISSUE, AND A SEPARATE ERROR POPPED UP STATING "CONTROL ISSUE ENCOUNTERS SHUT DOWN WORKSTATION AND TURN ON AGAIN". THE MANUFACTURER REPRESENTATIVE HAD TO THEN REDO THE SET-UP STEPS TO CONTINUE WITH CASE. HALFWAY THROUGH THE CASE THE ERROR ISSUE HAPPENED AGAIN WHILE MOUNTED TO THE PATIENT, SO THE MANUFACTURER REPRESENTATIVE HAD TO REDO THE 3 DEFINE. THE ERROR ISSUE HAPPENED A 3RD TIME AFTER UN-MOUNTING FROM THE BED. THE OUTLET WAS SWAPPED AFTER THE FIRST OCCURRENCE, HOWEVER THE ISSUE CONTINUED TO PERSIST. L4 TO L2 WERE FREEHANDED. IT WAS DURING THE FREEHAND PORTION THAT THE CONTROLLER ERROR/REBOOT REQUEST INITIALLY OCCURRED. AFTER RESETTING THE SYSTEM A CONFIRMATION SPIN WAS TAKEN. THE GUIDANCE SYSTEM THEN PRESENTED THE SAME CONTROLLER ERROR MESSAGES AND HAD TO BE SHUT DOWN/RESET BEFORE DOING THE FIRST REGISTRATION. THE FIRST SEGMENT OF SCREWS WERE PLACED ROBOTICALLY FROM L1 TO T8,

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREENS ON THE SYSTEM WENT BLACK TWICE BEFORE THE 3 DEFINE SCAN WAS COMPLETED. THE SCREEN WENT BLACK FOR ABOUT 90 SECONDS, AND ALL INSTRUMENTS WOULD HAVE TO BE REVERIFIED AFTER EACH INSTANCE. THE CODES REMAINED. THE SYSTEM WAS DELAYED BY TEN MINUTES. THE SURGEON PLANNED ON INSERTING FOUR SCREWS, BUT THE ANESTHESIOLOGIST ABORTED THE SURGERY DUE TO THE PATIENT'S HIGH BLOOD PRESSURE AFTER TWO SCREWS WERE INSERTED. THE THIRD SCREW WAS IN THE PROCESS OF BEING INSERTED WHEN THE SURGERY WAS ABORTED. THE MANUFACTURE REPRESENTATIVE BELIEVED THE ENTIRE SURGERY WOULD HAVE BEEN COMPLETED HAD THE SITE NOT FACED DELAYS. THERE WAS NO FURTHER PATIENT HARM REPORTED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A POSTERIOR INSTRUMENTATION WITH INTERBODY SPACERS AND FUSION OF L4-S1. IT WAS REPORTED THAT THIS SYSTEM COULD NOT PASS REGISTRATION DURING THE CASE. THE STAFF HOWEVER FELT LIKE THE ISSUE DID NOT LIE WITH THE GUIDANCE SYSTEM, BUT INSTEAD WITH THE SCANS. THE SURGERY WAS ABORTED AND WILL BE RESCHEDULED AFTER THE PATIENT LOSING SOME WEIGHT PER SURGEON REQUEST. THE SUSPECTED OR MOST LIKELY CAUSE OF THE REGISTRATION ISSUE WAS THE PATIENT'S BMI OR BMI GAIN SINCE THE CT SCAN. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE STAR MARKER COULD NOT BE FOUND. THE SITE DID AN HD SCAN AND DROPPED IT DOWN 3 AND STILL COULDN'T BE FOUND. THE SURGERY WAS ABORTED. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS ISSUE OCCURRED DURING SCAN PLAN. THE SURGERY WAS ABORTED POST-INCISION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022 THE PATIENT HAD SPINAL SURGERY WITH USE OF MAZOR ROBOTIC ASSISTANCE. PER THE SURGEON, DURING THE PROCEDURE THE EXPANDING TECHNOLOGY FAILED. ALSO POST OP, IT WAS SUSPECTED THAT THE SCREWS PLACED BY THE MAZOR WERE MALPOSITIONED FROM THE PLANNED TRAJECTORY. ANOTHER PROCEDURE WAS REQUIRED FOR SCREW REVISION AND COMPRESSION OF THE EXPANDABLE CAGE. FDA SAFETY REPORT ID # (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOTIC ASSISTED SURGERY IS CONTINUOUSLY GETTING MORE COMMON IN SPINAL SURGERY. MANY STUDIES HAVE ALREADY SHOWN AN IMPROVEMENT IN THE ACCURACY OF PEDICLE SCREW PLACEMENT AND A DECREASE OF SURGICAL REVISIONS. UP TO NOW ONLY A FEW STUDIES EXIST REGARDING THE LEARNING CURVE AND THE TIME NEEDED FOR ROBOTIC ASSISTED SPINAL FUSIONS. FOR GERMANY NO RELEVANT DATA ARE AVAILABLE SO FAR. THIS PROSPECTIVE AND COMPARATIVE STUDY FOCUSSED ON THE LEARNING CURVE COMPARED TO THE STANDARD SURGICAL PROCEDURE. MATERIAL AND METHODS: SINGLE-CENTER PROSPECTIVE DATA COLLECTION OF ALL PERFORMED SPINAL FUSIONS, WHETHER STANDARD OPEN (SO) OR ROBOTIC ASSISTED (RAS), OVER A PERIOD OF 5 MONTHS. EVALUATION OF TIME NEEDED FOR ROBOTIC REGISTRATION AND PEDICLE SCREW PLACEMENT, AMOUNT OF BLOOD LOSS, X-RAY DOSE, AND COMPLICATIONS. LEARNING CURVE WAS CALCULATED USING CURVE FITTING REGRESSION MODELS IN SPSS. RESULTS: 71 NON-RANDOMIZED PATIENTS WERE INCLUDED OF WHOM 42 (MEAN AGE 64 ± 15 YEARS) UNDERWENT ROBOTIC ASSISTED SURGERY (RAS) (MAZOR X STEALTH STATION, MEDTRONIC), 29 (MEAN AGE 63 ± 19 YEARS, P = 0.761) UNDERWENT STANDARD OPEN SURGERY (SO). THE AVERAGE NUMBER OF IMPLANTED SCREWS FOR SO WAS 6 ± 3, AND FOR

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A SINGLE POSITIONER LATERAL CASE FROM L2-L5. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN, SCHANZ BRIDGE AND MIS CONNECTOR. THE PATIENT WAS NOTED TO BE SMALL AND WAS POSITIONED WITH THEIR LEFT SIDE UP. THE SURGEON STARTED AT RIGHT L2 AND PLACED THE PEDICLE SCREWS UP BEFORE MOVING TO THE TOP SIDE LEFT AND GOING DOWN. DURING THE CASE, THE SURGEON FELT ACCURATE AND AN INTRA-OP X-RAY WAS TAKEN TO CONFIRM ACCURACY. WHEN THE SURGEON DRILLED LEFT L2, THE PATIENT HAD A BODILY RESPONSE AND BUCKED, WHICH DID NOT SEEM TO CAUSE ANY ISSUES AND THE CASE CONTINUED. THE SURGEON FINISHED THE LEFT SIDE, TOOK AN X-RAY AND PROCEEDED WITH THE OLIF PORTION. A DAY AFTER THE PROCEDURE, THE PATIENT HAD SERIOUS LEG WEAKNESS AND DISCOMFORT ON THEIR LEFT SIDE. A CT SCAN WAS DONE AND L2-L3 ON THE LEFT SIDE WERE FOUND TO BE DEVIATED 3-5 MM MEDIALLY AND L2-L3 ON THE RIGHT SIDE WERE 3-5 MM OFF LATERALLY. THE SURGEON BELIEVED THAT THE DRILL HIT THE NERVE ROOT WHEN THE PATIENT BUCKED. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE EVIDENCE POINTED TO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY ON (B)(6). IT WAS REPORTED THAT MULTIPLE SCREWS WERE DETERMINED TO BE MEDIALLY OFF VIA POST-OP SCAN. THE SITE REGISTERED VIA A CT TO FLUORO MERGE WITH A PERCUTANEOUS PIN IN THE PSIS. THE SCREWS WERE PLACED ACCURATELY BILATERALLY AT ALL LEVELS PER THE ROBOTIC PLAN. T8-L1 WERE THEN REGISTERED VIA CT TO FLUORO MERGE WITH THE BONE MOUNT CLAMP AT APPROXIMATELY T10-T11. THE SCREWS WERE PLACED ACCURATELY. THE FINAL THREE LEVELS T5-T7 WERE REGISTERED THE SAME WAY WITH THE BONE MOUNT CLAMP ON T7. WHEN BEGINNING TO PLACE THE FIRST SCREW AT T7, THERE WAS A SHOULDER SHIFT ERROR. THE ROBOT WAS REGISTERED AGAIN WITHOUT MOVING THE CLAMP AND, AGAIN, WHEN THE SITE STARTED PLACING THE T7 SCREW, THEY RECEIVED A SHOULDER SHIFT ERROR. THE CLAMP WAS REMOVED, AND IT WAS NOTICED THAT THE SPINOUS PROCESS HAD CRACKED. THE CLAMP WAS MOVED UP ONE LEVEL TO T6, AND THE ROBOT REGISTERED ONE LAST TIME TO PLACE THE SCREW BILATERALLY UP TO T5. NO INTRA-OPERATIVE IMAGING WAS TAKEN TO CONFIRM THE SCREW PLACEMENT. THE PATIENT WAS IN SOME PAIN POST OPERATIVELY. WHEN IT WA

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A PATIENT HAD RETURNED TO HAVE A SCREW DEVIATION CORRECTION COMPLETED FOR A SCREW THAT WAS PLACED USING THIS SYSTEM ON (B)(6). THE CASE WAS L4 TO S1 AND THE INACCURACY WAS BELIEVED TO BE CAUSED BY PATIENT SHIFT AND LOCATED ON THE L4 SCREW PLACEMENTS. THE SHIFT WAS BELIEVED TO BE ~4-5MM MEDIAL. THERE WAS NO KNOWN IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED FOOT DROP SYMPTOMS FROM THE MEDIAL PLACED SCREW.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A REVISION SURGERY, THE PATIENT HAD MISPLACED THORACIC SCREWS. ORIGINAL SURGERY OF PATIENT WAS ON (B)(6), CAME IN ON (B)(6) AND HAD REVISION SURGERY ON (B)(6). THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2022, HOWEVER THE PATIENT DID NOT COME BACK TO THE HOSPITAL UNTIL (B)(6) 2022 AND HAD REVISION SURGERY ON (B)(6) 2022. T11 TO L3 BURST FRACTURE AT L1. SURGEON WAS PLANNING ON PLACING SCREWS FROM T11 TO L3, INCLUDING SCREWS AT L1 IF IT WAS POSSIBLE. THE CASE WAS DONE MIS USING SOLERA 5.5/6.0 VOYAGER. THE RESIDENTS MADE A SMALL INCISION AND PLACED THE SINGLE AMBER CLAMP ON THE SPINOUS PROCESS OF L1. ALL THE STEPS WERE TAKEN TO ACQUIRE THE IMAGING SYSTEM SCAN WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE PLANNED THE SCREWS AS THE SURGEON WATCHED AND INFORMED THE REP WHERE HE WANTED THEM PLACED. THE PATIENT HAD VERY SMALL PEDICLES WITH SOME INTERESTING ANATOMY. THEY NOTED A POTENTIAL SKIVE AT T12 ON THE RIGHT. THEY STARTED AND THE RIGHT AND WENT TOP DOWN. THEY SENT EACH TRAJECTORY AND THE RESIDENTS MARKED THE SKIN. T

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L3-L4 MINI-OPEN TLIF WITH RADIOLUCENT RETRACTORS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE RIGHT SIDE OF THE PATIENT CONNECTED TO A BONE MOUNT BRIDGE. ALL SCREWS WERE ACCURATE EXCEPT FOR RIGHT L2. LEFT L2 WAS ACCURATELY PLACED. AT RIGHT L2, THE PATIENT JUMPED DURING DRILLING. THE RIGHT L2 TRAJECTORY WAS INITIALLY INFERIOR BY 3.5-10 MM WHEN TAKING FLUORO IMAGES. THE SURGEON WENT TO RIGHT L3 AND THE TRAJECTORY LOOKED OFF SO THEY WENT TO LEFT L3 AND L4 AND PLACED ACCURATE SCREWS. RIGHT L4 WAS THEN ACCURATELY PLACED. THE SURGEON WENT BACK TO RIGHT L2 AND REMOVED THE SCREW. REGISTRATION WAS REDONE. THE REGISTRATION SEGMENTATION LINES WERE ADJUSTED AT L2 INCASE THE LINES WERE PARTIALLY CUT OFF. THE SURGICAL ARM WAS SENT TO THE TRAJECTORY AND IMAGES WERE TAKEN WITH THE CANNULA, WHICH WAS ACCURATE. THE SCREW WAS TESTED AND CAME BACK AT 5. AN AP IMAGE WAS TAKEN AND THE SCREW WAS MEDIAL EVEN THOUGH NAVIGATION LOOKED ACCURATE. THE SCREW SKIVED BETWEEN 3.5-10 MM. THE SURGEON DECIDED TO ABORT THE USE OF THE GU

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE GUIDANCE SYSTEM WAS USED DURING A FRACTURE TRAUMA CASE. THREE DAYS LATER, A REVISION WAS DONE TO REVISE TWO BREACHED SCREWS AT T6. THE LEFT AND RIGHT T6 SCREWS WERE 2 MM MEDIAL TO PLAN. A C-ARM WAS USED TO REMOVE AND PLACE THE SCREWS AT T6. DURING THE INITIAL PROCEDURE, THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SPINOUS PROCESS CLAMP PLACED AT T9 AND THE BONE MOUNT BRIDGE. T7 WAS TOO UNSTABLE FOR THE CLAMP DUE TO THE FRACTURE AND THE SURGEON DID NOT WANT TO USE T8 SINCE THEY THOUGHT THE CLAMP WOULD BE IN THE WAY OF THE TRAJECTORY. A CT TO FLUORO WORKFLOW WAS USED AND SCREWS WERE PLACED AT LEFT T6 AND LEFT T8. THE SURGEON THEN SWITCHED TO THE RIGHT SIDE. NO NEUROMONITORING WAS DONE TO TEST MOTOR FUNCTION DUE TO THE PATIENT'S AIRWAY (TRACHEOSTOMY TUBE IN PLACE). THE SURGEON QUESTIONED ACCURACY DURING THE CASE AND A 10 POINT ACCURACY TEST WAS SUCCESSFULLY COMPLETED. NAVIGATION WAS ACCURATE WHEN CHECKED WITH THE PASSIVE PLANAR BEING PLACED ON THE SPINOUS PROCESS AND THE DIVOT ON THE ARM GUIDE. THE SURGEON WAS ON TRAJECTORY WITH THE TAP, SCREW, AND DILATO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L4/L5 CASE. THE LEFT L4 SCREW WAS MEDIAL AND BREACHED THE CANAL. NAVIGATION WAS USED WITH THE DILATOR, BUT NOT WHEN PLACING THE SCREWS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE PSIS. ACCURACY WAS NOT CHECKED THROUGHOUT THE PROCEDURE. THE SURGEON DID NOT THINK THE DEVIATION WAS DUE TO THE GUIDANCE SYSTEM AND THEY THOUGHT THE RETRACTOR PUSHED THE CANNULA MEDIALLY. THE AMOUNT OF DEVIATION WAS UNKNOWN. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND THE SCREW WAS REPOSITIONED USING NAVIGATION. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE MULTIPLE BREACHES DURING THE T9-L4 FUSION WITH ADDITIONAL RESECTIONS AND MODIFICATIONS. THE SURGICAL SYSTEM WAS MOUNTED USING A CLAMP AND SCHANZ PIN. THE PATIENT WAS NOTED TO HAVE A BMI OVER 40. THE CASE WAS SEPARATED INTO TWO SEGMENTS, T9-T11 AND T12-L4. WHEN SETTING UP THE CASE, THE 3 DEFINE SCAN FAILED SO A GENERIC WORK VOLUME WAS USED FOR THE FIRST SEGMENT. THE SURGEON HAD SOME DIFFICULTY WITH REGISTRATION, BUT THEY WERE EVENTUALLY ABLE TO GET THE SEGMENT REGISTERED. THE SURGICAL ARM WAS SENT TO THE RIGHT T9 TRAJECTORY, BUT THE TRAJECTORY LOOKED MEDIAL. THE PLAN WAS ADJUSTED AND THE SURGICAL ARM WAS RESENT TO THE TRAJECTORY. AFTER DRILLING, THE SURGEON NOTICED A CSF LEAK AND THEY FOUND A MEDIAL BREACH USING A PROBE. THE PLACEMENT OF THE SCREW WAS ADJUSTED AND THE SURGEON CONTINUED TO PLACE SCREWS THROUGH T11 LEFT AND RIGHT WITHOUT ISSUE AND JUST MINOR ADJUSTMENTS TO PLAN. EACH SECTION WAS PROBED BY THE SURGEON AND NO BREACHES WERE FOUND. THE SURGEON THEN MOVED TO THE SECOND SEGMENT. DUE TO RESECTION, NAVIGATION WITH A PERCUTANEOUS PIN REFERENCE FRAME

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A SCAN PLAN L1-L4 FUSION TRANS-FACIAL PROCEDURE. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SPINAL PROCESS CLAMP AT L2. RIGIDITY WAS CHECKED BY THE SURGEON AND THEY FELT THE MOUNT WAS SOLID. BILATERAL RETRACTION WAS VERY LIGHT AND USED ON THE SKIN. THE PATIENT HAD FRACTURES AT L2 AND L3. THERE WAS A 2 CM SHIFT DURING THE PROCEDURE. THE LEFT L1 SCREW WENT LATERAL AND THE RIGHT L1 SCREW WENT THROUGH THE CANAL. THE SCREWS WERE REMOVED. SEVEN SPINS WERE TAKEN TO IDENTIFY THE DEVIATION. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND PLACE SCREWS AT L1 USING NAVIGATION. THE PROCEDURE WAS DELAYED AN HOUR.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE MULTIPLE MISPLACED SCREWS DURING THE PROCEDURE. ALL OF THE MISPLACED SCREWS WERE MEDIAL BETWEEN 3.5-10 MM. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ ARM CONNECTED TO A SCHANZ PIN PLACED IN THE RIGHT PSIS. THE SURGEON WAS ON THE LEFT SIDE OF THE PATIENT AND IMPLANTED IPSILATERAL PEDICLE SCREWS FROM L4-S1. THE SURGEON THEN IMPLANTED IPSILATERAL L4-S1 FROM THE RIGHT SIDE. THEN THEY IMPLANTED A CONTRALATERAL S2AI SCREW FROM THE PATIENT'S RIGHT. THE SURGEON FINALLY IMPLANTED THE PATIENT'S RIGHT S2AI SCREW FROM THE LEFT SIDE OF THE PATIENT. ALL WERE MEDIAL EXCEPT ONE OF THE S2 SCREWS. AN ACCURACY CHECK HAD BEEN RUN AFTER PLACING THE L5 RIGHT AND THE SYSTEM APPEARED ACCURATE AT THAT TIME. NO PATIENT SHIFT OR SOFT TISSUE TENSION WAS NOTED WHEN PLACING THE SCREWS DURING THIS OPEN PROCEDURE. MINIMAL RETRACTION WAS NEEDED. THE MALIGNED SCREWS WERE NOTICED IN A POSTOP CT SCAN. THERE WAS NO SPIN PERFORMED TO CHECK THE PLACEMENT OF THE IMPLANTS INTRAOPERATIVELY. A SEPARATE REVISION WAS PLANNED TO REVISE THE SCREWS. THE PROCEDURE WAS NOT DELAYED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE REGISTRATION ISSUES DURING A L3-S1 OLIF OPEN PROCEDURE. A 3 LEVEL OLIF WAS PERFORMED WITH LATERAL PLATE AT L5/S1 PRIOR TO REGISTRATION. THE SYSTEM WOULD NOT REGISTER L4-S1, BUT L3 HAD YELLOW VALUES. THE CT SCAN USED DID NOT HAVE CAGES OR PLATES IN IT. THE MANUFACTURER REPRESENTATIVE TRIED MANUAL REGISTRATION AND USING MULTIPLE IMAGES WITHOUT SUCCESS. A NEW OBLIQUE IMAGE WAS ACQUIRED, BUT REGISTRATION WAS STILL UNSUCCESSFUL. SCREWS WERE PLACED AT L3, BUT THE SURGEON DECIDED TO BRING IN AN O-ARM AND PLACE SCREWS AT L4-S1 USING A SCAN <(>&<)> PLAN WORKFLOW. THE S1 SCREW WAS FOUND TO BE MEDIAL DURING THE PROCEDURE. THE TRAJECTORY WAS RE-PLANNED AND WAS PLACED ACCURATELY. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. A POST-OP CT SCAN SHOWED THAT THE RIGHT L3-L5 SCREWS WERE ALL MEDIAL. THE SCREWS WERE DEVIATED 5.5 TO 6.5 MM ON AVERAGE. THE PATIENT WAS EXPERIENCING WEAKNESS IN THEIR RIGHT LEG. A REVISION PROCEDURE WAS DONE USING THE GUIDANCE SYSTEM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE 90-DAY COMPLICATION RATES BETWEEN ROBOTIC-ASSISTED AND NON-ROBOTIC-ASSISTED LUMBAR SPINAL FUSIONS IN PROPENSITY-MATCHED C OHORTS. A RECENT ADMINISTRATIVE DATABASE (PEARLDIVER) STUDY REPORTED INCREASED 30-DAY COMPLICATIONS WITH THE UTILIZATION OF ROBOTIC-ASSISTED ENABLING TECHNOLOGY. OF 146 ROBOTIC-ASSISTED CASES THAT MET INCLUSION CRITERIA, 114 WERE SUCCESSFULLY PROPENSITY MATCHED TO 114 PATIENTS FROM 214 CASES WHO HAD 1 TO 3 LEVEL LUMBAR FUSION WITHOUT ROBOTIC ASSISTANCE BASED ON AGE, SEX, BODY MASS INDEX, SMOKING STATUS, AMERICAN SOCIETY OF ANESTHESIOLOGIST GRADE, NUMBER OF SURGICAL LEVELS, PRIMARY VERSUS REVISION, AND SURGICAL APPROACH (POSTERIOR-ONLY OR ANTERIOR-POSTERIOR). WE EXCLUDED TUMOR, TRAUMA, INFECTION, OR DEFORMITY CASES. OUTCOMES INCLUDED SURGICAL AND MEDICAL (MAJOR/MINOR) COMPLICATIONS AT INTRAOPERATIVE, IMMEDIATELY POSTOPERATIVE, 30- AND 90-DAY POSTOPERATIVE INTERVALS, INCLUDING REOPERATIONS, AND READMISSIONS WITHIN 90 DAYS. ALL CAUSE INTRAOPERATIVE COMPLICATION RATES WERE SIMILAR BETWEEN NON-ROBOTIC-ASSISTED (5.3%) AND ROBOTIC-ASSISTED GROUPS (10.5%, P¼0.366). IMMEDIATE POSTOPERATIVE MEDICAL COMPLICATION RATE WAS ALSO SIMILAR BETWEEN NON-ROBOTI

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L3-L4 TLIF PROCEDURE. THE DEVIATION WAS FOUND DURING A POST-OP CT SCAN. THE SCAN SHOWED THAT THE LEFT SIDE SCREWS WERE SHIFTED MEDIAL AND THE RIGHT SIDE SCREWS WERE SHIFTED LATERAL TO PLAN BY 4-6 MM. DURING THE INITIAL PROCEDURE, A SCHANZ PIN WAS PLACED IN THE LEFT PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE SURGEON PLACED SCREWS WORKING FROM RIGHT TO LEFT STARTING AT L3. THE MANUFACTURER REPRESENTATIVE SUSPECTED THE DEVIATIONS WERE DUE TO A PATIENT SHIFT. A REVISION PROCEDURE WAS DONE TO REVISE THE SCREWS. THE REPRESENTATIVE NOTED THAT IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS RELATED TO THE DEVIATIONS.