Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FARIVAR, D., KIM, T. T., SY, C. A., BARON, E. M., NOMOTO, E. K., WALKER, C. T., & AMP; SKAGGS, D. L. (2023). COMPLICATIONS HAVE NOT IMPROVED WITH NEWER GENERATION ROBOTS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682231216081 OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO SEE WHETHER UPGRADES IN NEWER GENERATION ROBOTS IMPROVE SAFETY AND CLINICAL OUTCOMES FOLLOWING SPINE SURGERY. METHODS: ALL PATIENTS UNDERGOING ROBOTIC-ASSISTED SPINE SURGERY WITH THE MAZOR X STEALTH EDITIONTM (MEDTRONIC, MINNEAPOLIS, MN) FROM 2019 TO 2022 AT A COMBINED ORTHOPEDIC AND NEUROSURGICAL SPINE SERVICE WERE RETROSPECTIVELY REVIEWED. ROBOT RELATED COMPLICATIONS WERE RECORDED. RESULTS: 264 CONSECUTIVE PATIENTS (54.1% FEMALE; AGE AT TIME OF SURGERY 63.5 ± 15.3 YEARS) OPERATED ON BY 14 SURGEONS WERE ANALYZED. THE AVERAGE NUMBER OF INSTRUMENTED LEVELS WITH ROBOTICS WAS 4.2 ± 2.7, WHILE THE AVERAGE NUMBER OF INSTRUMENTED SCREWS WITH ROBOTICS WAS 8.3 ± 5.3. THERE WAS A NEARLY 50/50 SPLIT BETWEEN AN OPEN AND MINIMALLY INVASIVE APPROACH. SIX PATIENTS (2.2%) HAD ROBOT RELATED COMPLICATIONS. THREE PATIENTS HAD TEMPORARY NERVE ROOT INJURIES FROM MISPLACED SCREWS THAT REQUIRED REOPERATION, ONE PATIENT HAD A PERM

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 L2 LEFT WAS ACCURATE. THE SITE MOVED TO L3 LEFT AND UPON TAPPING THE ARM, THE SYSTEM STATED IT FELT A FORCE AND WAS NOT ON TRAJECTORY. THE ARM WAS MOVED AWAY AND THE ARM WAS RESENT TO L3 LEFT AND THE SCREW LOOKED ACCURATE, BUT IT WAS NOT ACCURATE. THE SCREW WAS REPOSITIONED MANUALLY, BUT IT APPEARED THAT THE NERVE ROOT WAS DAMAGED. ALL THE OTHER SCREWS WERE ACCURATE. 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: TOMOYUKI ASADA , CHAD Z. SIMON , AMY Z LU , SAMUEL ADIDA , MARCEL DUPONT , PHILIP M PAREL , JOSHUA ZHANG , SATYAJ BHARGAVA , KYLE W. MORSE , JAMES E. DOWDELL , SRAVISHT IYER , SHEERAZ A QURESHI , ROBOT-NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE INTRAOPERATIVE BLOOD LOSS AND LENGTH OF HOSPITAL STAY: ANALYSIS OF 1,633 PATIENTS UTILIZING PROPENSITY SCORE MATCHING, THE SPINE JOURNAL (2023), DOI: HTTPS://DOI.ORG/10.1016/J.SPINEE.2023.09.004 BACKGROUND CONTEXT: NAVIGATION AND ROBOTIC TECHNOLOGIES HAVE EMERGED AS AN ALTERNATIVE OPTION TO CONVENTIONAL FREEHAND TECHNIQUES FOR PEDICLE SCREW INSERTION. HOWEVER, THE EFFECTIVENESS OF THESE TECHNOLOGIES IN REDUCING THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY REMAINS LIMITED DUE TO THE SMALL COHORT SIZE IN THE EXISTING LITERATURE. PURPOSE: TO INVESTIGATE WHETHER UTILIZATION OF ROBOTICALLY NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY¿INCLUDING REOPERATIONS¿WITH A SIZEABLE COHORT. STUDY DESIGN: RETROSPECTIVE STUDY. PATIENT SAMPLE: PATIENTS WHO UNDERWENT PRIMARY LUMBAR FUSION SURGERY BETWEEN 2019 AND 2022. OUTCOME MEASURES: PERIOPERATIVE COMPLICATIONS INCLUDING READMISSION, REOP

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA K, GLASSMAN SD, BROWN ME, DANIELS CL, SCHMIDT GO, CARREON LY, HINES B, GUM JL. RISK FACTORS OF SCREW MALPOSITION IN ROBOT-ASSISTED CORTICAL BONE TRAJECTORY: ANALYSIS OF 1344 CONSECUTIVE SCREWS IN 256 PATIENTS. SPINE (PHILA PA 1976). 2023 SEP 28. DOI: 10.109 7/BRS.0000000000004827. EPUB AHEAD OF PRINT. PMID: 37767783. OBJECTIVE: TO DESCRIBE THE INCIDENCE OF AND IDENTIFY RISK FACTORS FOR INTRAOPERATIVE SCREW MALPOSITION SECONDARY TO SKIVE OR SHIFT DURING ROBOT-ASSISTED CORTICAL BONE TRAJECTORY (RACBT) INSERTION. METHODS: A CONSECUTIVE SERIES OF PATIENTS OLDER THAN 18 YEARS WHO UNDERWENT RA-CBT SCREW PLACEMENT BETWEEN JANUARY 2019 AND JULY 2022 WERE ENROLLED. BASELINE DEMOGRAPHIC AND SURGICAL DATA, HOUNSFIELD UNITS (HU) AT L1, AND VERTEBRAL SHAPE RELATED TO SCREW PLANNING WERE COLLECTED. SKIVE OR SHIFT WAS RECORDED IN THE OPERATING ROOM ON A DATA COLLECTION FORM. RESULTS: OF 1344 CBT SCREWS IN 256 PATIENTS, MALPOSITION WAS RECOGNIZED INTRAOPERATIVELY IN 33 SCREWS (2.4%) IN 27 PATIENTS (10.5%); 19 VIA SKIVE IN 17 AND 14 VIA SHIFT IN 10 PATIENTS. THESE PATIENTS HAD HIGHER BMI THAN PATIENTS WITHOUT MALPOSITION (33.0 KG/M2 VS 30.5 KG/M2, P=0.037). PATIENTS WITH SKIVE HAD HIGHER HU

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