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 TWO SCREWS WERE PLACED AND THE SURGEON NOTED THAT THEY WERE POSITIONED MORE MEDIALLY THAN INTENDED. THIS RAISED CONCERNS ABOUT ALLEGED INACCURACY OF THE GUIDANCE SYSTEM. THE SURGEON PERFORMED A SECOND MEDTRONIC IMAGING SPIN AND TRANSFERRED THE NEW IMAGES TO THE GUIDANCE SYSTEM. BEFORE PLACING A THIRD SCREW, THE SURGEON DECIDED TO ABORT USE OF THE GUIDANCE SYSTEM. ALL SCREWS WERE REMOVED FROM THE PATIENT AND THE GUIDANCE SYSTEM WAS REPLACED WITH A NAVIGATION SYSTEM FOR RE-PLACEMENT OF THE SCREWS. IT WAS NOTED THAT THERE WERE TWO UNUSED STANDARD SPINS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT AND SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORIES WERE NOTED TO DEVIATE BETWEEN 3.5 AND 10 MILLIMETERS (MM) ON ALL THREE OF THE ORIGINALLY PLACED SCREWS, BASED ON MEASUREMENTS FROM THE SECOND COMPLETED MEDTRONIC IMAGING SPIN, MEASURING FROM THE SCREW THAT WAS STILL PLACED AS WELL AS NOTED PATH SEEN ON IMAGING FROM WHERE SCREWS HAD BEEN REMOVED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE REPORTED ADVERSE EVENTS WERE RELATED TO THE GUIDANCE SYSTEM.

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAITY, APRATIM, ET AL. ¿ANALYSIS OF ROOT CAUSES OF ADVERSE EVENTS WITH MAZOR X AND MAZOR X STEALTH EDITION-GUIDED SPINE SURGERIES: AN FDA MAUDE DATABASE STUDY.¿ EUROPEAN SPINE JOURNAL, 22 DEC. 2025, HTTPS://DOI.ORG/10.1007/S00586-025-09683-2. ABSTRACT PURPOSE: THIS STUDY AIMED TO ANALYZE ADVERSE EVENTS ASSOCIATED WITH MAZOR X SURGICAL GUIDANCE ROBOTS, FOCUSING ON PARAMETERS SUCH AS ROOT CAUSES, VERTEBRAL DISTRIBUTION, SURGICAL DELAY, ROBOT ABANDONMENT, AND MORE. METHODS: 330 ADVERSE EVENTS REPORTED WITHIN THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) DATABASE FOR THE MAZOR X (MX) AND MAZOR X STEALTH EDITION (MXSE) ROBOT GUIDANCE SYSTEMS WERE ANALYZED AND CATEGORIZED BASED ON THE ROOT CAUSES, VERTEBRAL DISTRIBUTION, SURGICAL DELAY, ROBOT ABANDONMENT, AND PATIENT OUTCOMES. RESULTS: BOTH THE MX AND MXSE ADVERSE EVENTS WERE PRIMARILY DUE TO EXTERNAL ROOT CAUSES (35% AND 52%, RESPECTIVELY), WITH USER ERROR BEING THE MOST COMMON. DEVIATIONS WERE MOST LIKELY TO AFFECT THE L3, L4, AND L5 VERTEBRA, AND DEVIATE EITHER MEDIALLY OR LATERALLY. MOTOR DEFICITS WERE THE MOST COMMON ADVERSE PATIENT OUTCOME FOR MX, WHILE SENSORY DEFICITS WERE THE MOST COMMON FOR MXSE. THERE WERE TWO D

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON DID NOT EXPOSE THE PROXIMAL LUMBAR ANATOMY (L2). WHEN THE MANUFACTURING REPRESENTATIVE (REP) SENT THE ARM TO THE L2 TRAJECTORY, THE SURGEON THOUGHT SHE EXPOSED L2 WHEN IN FACT SHE EXPOSED UP TO L3. SO, SHE SAID THE TRAJECTORY WAS OFF. THEY THEN TOOK AN AP SHOT WITH THE IMAGING SYSTEM TO VERIFY THE EXPOSED LUMBAR ANATOMY. AFTER VERIFICATION, THE SURGEON REALIZED THAT SHE DID NOT EXPOSE L2 AND THAT THE TRAJECTORY WAS CORRECT. ONCE THE ARM WAS SENT TO THE L2 TRAJECTORY AFTER RE EXPOSING THE CORRECT ANATOMY (L2), THE CANNULA WAS PASSED DOWN THE ARM GUIDE AND THE TRAJECTORY IMAGING SHOWED NO DEVIATION. THE SURGEON THEN PLACED THE DRILL FOR THE GUIDANCE SYSTEM DOWN THE GUIDE AND AGAIN THERE WERE NO DEVIATIONS. THE SURGEON THEN PASSED THE DRILL. AFTER DRILLING WITH THE DRILL FOR THE GUIDANCE SYSTEM, THE SURGEON THEN PASSED THE TAP AND AGAIN THERE WERE NO DEVIATIONS. THE REP STATED THAT AFTER LOOKING BACK THROUGH HIS REPORT, THERE WAS NOT AN INITIAL REPORT THAT THERE WAS CLEAR INACCURACY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ETIGUNTA, S. K., WALKER, C. T., GAUSPER, A., GALOUSTIAN, N., LIU, A., GOWD, A. K., CHAN, V., ANAND, N., NOMOTO, E., PERRY, T. G., SODHA, S., JOHNSON, J. P., SKAGGS, D. L., KIM, T. (2025). DECREASED ROBOT-RELATED COMPLICATIONS FOLLOWING THE DEVELOPMENT AND ADOPTION OF A STANDARDIZED SAFETY PROTOCOL. JOURNAL OF BONE AND JOINT SURGERY, 108(1), 45¿50. HTTPS://DOI.ORG/10.2106/JBJS.25.00406 SUMMARY: BACKGROUND: ROBOT-ASSISTED SPINE SURGERY (RASS) ENABLES PRECISE PEDICLE SCREW INSERTION VIA PRE-PLANNED TRAJECTORIES, AND YET COMPLICATIONS REMAIN A NOTABLE CONCERN. PRIOR WORK SUGGESTS THAT OSSEOUS PEDICLE WALL BREACHES FROM INSTRUMENTATION AND ENSUING COMPLICATIONS RELATED TO ROBOTIC SURGERY MAY BE FROM SHIFTING OF THE REFERENCE FRAME OR IMPROPER METHODOLOGY. IN THIS STUDY, WE HYPOTHESIZED THAT THE INTRODUCTION OF STANDARDIZED INSTITUTIONAL GUIDELINES FOR RASS WOULD REDUCE COMPLICATIONS ASSOCIATED WITH ROBOTIC SCREW PLACEMENT. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED PATIENTS WHO UNDERWENT RASS USING 2 ROBOTIC SYSTEMS AT A SINGLE INSTITUTION. WE ANALYZED THE CASES OF 264 PATIENTS IN A HISTORICAL COHORT BEFORE, AND 290 PATIENTS AFTER, THE IMPLEMENTATION OF A STANDARDIZED INSTITUTION

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 PLANNED SURGICAL TRAJECTORIES WERE HIGHER ON THE PATIENT THAN INTENDED (TOWARDS THE HEAD). AFTER ADJUSTING THE ANGLE OF THE C-ARM, THE SURGERY PROCEEDED. FOLLOWING THE INITIAL SURGERY, IT WAS DETERMINED THAT SCREWS HAD BEEN MISPLACED, AND THE PATIENT REQUIRED A RETURN TO SURGERY FOR MANUAL SCREW PLACEMENT (REVISION SURGERY). THE PATIENT REPORTED LEFT LEG PAIN AND WEAKNESS FOLLOWING THE INITIAL SURGERY, WHICH LESSENED AFTER THE REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TRAJECTORY DEVIATION WAS LIKELY IN THE 3.5-10 MILLIMETER (MM) RANGE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAVARRO-GARCIA DE LLANO, J. P., RIOS-ZERMENO, J., ROBERTS, A. P., IYER, H. G., SANCHEZ-GARAVITO, J. E., SAFA, A., MARTIN DEL CAMPO, I., GRAEPEL, S., PATTERSON, J. S., WHITE, K. E., BOJAXHI, E., NAVARRO-RAMIREZ, R., QUIÑONES-HINOJOSA, A., AKINDURO, O. O., BUCHANAN, I. A., CHEN, S. G., <(>&<)> ABODE-IYAMAH, K. (2025). SPINAL VERSUS GENERAL ANESTHESIA IN ROBOTIC MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A COMPARATIVE STUDY ON SURGICAL OUTCOMES. JOURNAL OF NEUROSURGERY: SPINE, 1¿9. HTTPS://DOI.ORG/10.3171/2025.6.SPINE25442 SUMMARY OBJECTIVE: THE IMPLEMENTATION OF ROBOTICS AND SPINAL ANESTHESIA (SA) IN SPINE SURGERY IS RAPIDLY EXPANDING, OFFERING SIGNIFICANT BENEFITS FOR AN INCREASINGLY COMPLEX AND AGING PATIENT POPULATION WITH DEGENERATIVE SPINAL DISEASE. HERE, THE AUTHORS PRESENT THE LARGEST COHORT TO DATE EVALUATING THE COMBINED USE OF THESE TWO TECHNIQUES IN MINIMALLY INVASIVE (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). METHODS: THE AUTHORS RETROSPECTIVELY ANALYZED SURGICAL OUTCOMES OF A SERIES OF PATIENTS WHO UNDERWENT ROBOT-ASSISTED (RA)¿MIS TLIF UNDER SA AND GENERAL ANESTHESIA (GA) AT THEIR INSTITUTION FROM 2018 TO 2024. PRIMARY OUTCOMES INCLUDED OPERATI

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 A CT REVEALED FORAMINAL STENOSIS DUE TO A FRACTURE OF THE PATIENT'S SUPERIOR ARTICULAR PROCESS POST-OPERATIVELY. ADDITIONALLY, THE PATIENT HAS INCREASED LEFT LEG PAIN. IT WAS NOTED THE GUIDANCE ROBOT WAS USED FOR THE DECORTICATION OF THE BONE. THE PROCEDURE PERFORMED WAS A INTERBODY FUSION FROM LEVELS L5-S1. ADDITIONAL SURGERY WAS PERFORMED THE DAY AFTER TO ADDRESS THE ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE GUIDANCE SYSTEM WAS INVOLVED IN AN ABNORMAL DECORTICATION. THE SYSTEM WAS USED TO DECORTICATE AND CANNULATE THE PEDICLE. AN APPROPRIATE SIZED SCREW WAS PLACED. POST-OP, THE PATIENT INDICATED THAT THEY HAD EXTREME PAIN. THE FRACTURED PROCESS HAD BEEN CANNULATED BY 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: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. IT WAS STATED THAT DURING NAVIGATION, THE TRAJECTORIES APPEARED TO BE ACCURATE, BUT AFTER PLACING T4 SCREW ON THE RIGHT SIDE, THE SURGEON WAS NOTIFIED BY NEURO-MONITORING TEAM THAT THEY HAD LOST READINGS OF THE PATIENT'S RIGHT LEG. AFTER TAKING AN IMAGE TO CONFIRM SCREW PLACEMENT, THE SCREW APPEARED TO BE PLACED MEDIALLY BY AN UNKNOWN AMOUNT OF UNITS. THEY TOOK OUT THIS SCREW AND ABANDONED USE OF THE ROBOT AND CLOSED THE PATIENT. THEY RE-PLACED THIS SCREW USING THE MEDTRONIC NAVIGATION SYSTEM DURING A FOLLOW UP SURGERY ON (B)(6) 2025. THE PATIENT WAS BEING MONITORED FOR PARALYSIS ON THE RIGHT LEG. SURGICAL DELAY WAS NOTED AS 5-10 MINUTES. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SITE REGISTERED ONCE, BUT THE C-ARM BUMPED THE ROBOT ON THE WAY OUT, SO THEY HAD TO REGISTER A SECOND TIME. IT WAS ALSO NOTED THAT THE PLANNED TRAJECTORY AT T4 ON THE RIGHT, WAS ORIGINALLY WITHIN THE PREFERRED PARAMETERS FOR AN OPEN CASE, HOWEVER, UPON DRILLING AT THE ORIGINAL TRAJECTORY THE DOCTOR FELT THEY WERE TO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SEIF, HASSAN, ET AL. ¿A RETROSPECTIVE COHORT STUDY COMPARING ROBOT-ASSISTED AND CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENT.¿ JOURNAL OF CLINICAL MEDICINE, VOL. 14, NO. 19, 26 SEPT. 2025, PP. 1¿14, HTTPS://DOI.ORG/10.3390/JCM14196831. BACKGROUND/OBJECTIVES: PEDICLE SCREW PLACEMENT IS CRUCIAL FOR RESTORING STABILITY. EMERGING ROBOT-ASSISTED TECHNOLOGIES MAY OFFER ENHANCED PRECISION AND REDUCED RADIATION EXPOSURE. THIS STUDY AIMED TO COMPARE THE ACCURACY AND CLINICAL OUTCOMES OF ROBOT-ASSISTED VERSUS CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENTS. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED 218 PATIENTS UNDERGOING PEDICLE SCREW PLACEMENT AT A SINGLE SPINE CENTER BETWEEN 2019 AND 2023. OF THESE, 105 PATIENTS UNDERWENT ROBOT-ASSISTED SURGERY USING THE MAZOR X¿ STEALTH EDITION (MEDTRONIC, MINNEAPOLIS, MN, USA), AND 113 UNDERWENT CONVENTIONAL FLUOROSCOPY-GUIDED SURGERY. THE PRIMARY OUTCOME WAS SCREW PLACEMENT ACCURACY (GRADE 0 = OPTIMAL, GRADES 1¿3 = SUBOPTIMAL, ACCORDING TO THE GERTZBEIN¿ROBBINS CLASSIFICATION). SECONDARY OUTCOMES INCLUDED ESTIMATED BLOOD LOSS (EBL), RADIATION EXPOSURE, LENGTH OF HOSPITAL STAY (LOS), CLINICAL OUTCOME ACCORDING TO 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 AN L2-L3 FUSION PROCEDURE USING COMPUTED TOMOGRAPHY-FLUORO REGISTRATION, NAVIGATION WITH THE GUIDANCE SYSTEM APPEARED TO BE INACCURATE BY 2 MILLIMETERS (MM), DEEP ON THE RIGHT SIDE OF L2 WHEN USING THE DILATOR OR THE PASSIVE PLANAR PROBE. THIS RESULTED IN A NERVE INJURY TO THE PATIENT. ANOTHER SNAPSHOT WAS PERFORMED AS A TROUBLESHOOTING STEP, WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS THEN RE-REGISTERED, WHICH RESOLVED THE NAVIGATION INACCURACY. SURGICAL DELAY WAS LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SOME NUMBNESS/TINGLING. THEY HAD NOT MOBILIZED MUCH AS THEY WERE STILL RECOVERING, SO IT WAS UNKNOWN WHETHER IT WOULD MATERIALIZE TO ANY SORT OF DEFICIT.

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, A T1-T12 SPINAL FUSION. IT WAS REPORTED THAT AN ALLEGED INACCURACY OCCURRED. INITIALLY, THE FIRST SURFACE SCAN WAS DELETED WITHOUT USER ACTION, AND THE SECOND SURFACE SCAN WAS UNUSABLE DUE TO A SHOULDER SHIFT. A THIRD SURFACE SCAN WAS SUCCESSFULLY PERFORMED. MEDTRONIC IMAGING WAS CONDUCTED FOR SCREW PLACEMENT PLANNING AND VERIFICATION. THE FIRST SCREW WAS PLACED, BUT WHEN THE ROBOT ARM WAS MOVED TO THE SECOND SCREW LOCATION, THE SURGEON OBSERVED THAT THE LOCATION APPEARED INACCURATE. THE ROBOT ARM USE WAS HALTED, AND CHICKENFOOT WAS USED TO CONFIRM THE LOCATION OF THE FIRST SCREW PLAN, REVEALING THAT THE PLAN WAS APPROXIMATELY 1 CENTIMETER (CM) LATERAL TO THE ACTUAL FIRST SCREW PLACEMENT. THE GUIDANCE SYSTEM USE WAS ABORTED. THE SURGICAL TEAM SWITCHED TO MEDTRONIC IMAGING AND NAVIGATION SYSTEM FOR PLACEMENT OF THE REMAINING SCREWS. MEDTRONIC IMAGING SHOWED THAT THE FIRST SCREW APPEARED TO BE 1 CM MEDIAL OF THE ORIGINALLY PLANNED LOCATION, AND IT WAS REPORTED THAT THE SCREW PENETRATED THE CANAL AT P1. A CEREBROSPINAL FLUID (CSF) LEAK WAS IDENTIFIED AND WAS REPORTEDLY BEING ADDRESSED DURI

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IAO, C., GUO, X., QIU, W., QI, Q., GUO, Z., SUN, C., ZHONG, W., & LI, W. (2025). RETROSPECTIVE ANALYSIS OF CLINICAL MANAGEMENT STRATEGIES FOR CAGE RETROPULSION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION. ORTHOPAEDIC SURGERY, 17(11), 3133¿3141. HTTPS://DOI.ORG/10.1111/OS.70174 SUMMARY OBJECTIVES: CAGE RETROPULSION (CR) IS A COMMON COMPLICATION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION (PLIF). SYMPTOMATIC PATIENTS WITH CR OFTEN REQUIRE REVISION SURGERY. HOWEVER, THERE IS A LACK OF LITERATURE SUPPORTING THE EFFECTIVENESS OF CONSERVATIVE TREATMENT FOR CR. THIS STUDY COMPARES CLINICAL AND RADIOGRAPHIC OUTCOMES BETWEEN CONSERVATIVE TREATMENT AND REVISION SURGERY IN PATIENTS WITH CR AFTER PLIF. METHODS: A TOTAL OF 55 PATIENTS WITH CR AFTER PLIF TREATED AT OUR INSTITUTION BETWEEN 2016 AND 2023 WERE RETROSPECTIVELY REVIEWED; P OSTOPERATIVE RADIOGRAPHIC DATA OF FOLLOW-UP WERE USED TO DIAGNOSE CR. CLINICAL OUTCOMES WERE ASSESSED BEFORE THERAPY AND AT THE FINAL FOLLOW-UP USING THE VISUAL ANALOG SCALE (VAS) FOR LOWER BACK PAIN AND LEG PAIN, OSWESTRY DISABILITY INDEX (ODI) SCORES, AND JAPANESE ORTHOPEDIC ASSOCIATION 29 (JOA-29) SCORES. THE TREATMENT EFFECTIVENESS WAS EVALUATED BASED ON WHETHE

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 INACCURATE REFERENCE, WHICH LED TO PATIENT HARM.

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 INACCURATE REFERENCE, WHICH LED TO PATIENT HARM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IACCARINO, F., DUGONI, D. E., PAVESI, G., LANDI, A., GALLIENI, M., GIORDANO, M., IACCARINO, C. (2025). ROBOTIC SPINE SURGERY COMPARED WITH FLUOROSCOPIC-ASSISTED SURGERY: ADVANTAGES, DISADVANTAGES, FUTURE PERSPECTIVES. JOURNAL OF ROBOTIC SURGERY, 19(1). HTT PS://DOI.ORG/10.1007/S11701-025-02654-1 SUMMARY: BACKGROUND: ROBOTIC SPINE SURGERY (RSS) COULD POTENTIALLY OVERCOME SOME LIMITATIONS OF FLUOROSCOPIC-ASSISTED SURGERY (FAS). THE AIM OF THIS STUDY WAS TO ANALYZE RSS ADVANTAGES COMPARED TO FAS AND THE IMPACT OF A DEDICATED NURSING TEAM ON SURGICAL WORKFLOW EFFICIENCY. MATERIALS AND METHODS: WE RETROSPECTIVELY ANALYZED 260 ADULT PATIENTS WITH THORACOLUMBAR DEGENERATIVE/TRAUMATIC INSTABILITY. ONE-HUN DRED-THIRTY UNDERWENT POSTERIOR FUSION WITH MEDTRONIC MAZOR X, WHILE 130 WERE TREATED WITH FAS. PARAMETERS INCLUDED OPERATIVE DURATION, OR ENTRY-TO-START TIME, SCREW IMPLANTATION TIME, ACCURACY (GERTZBEIN-ROBBINS CLASSIFICATION), RADIATION EXPOSURE, COMPLICATIONS, AND OSWESTRY DISABILITY INDEX (ODI). WE ALSO ASSESSED OR ENTRY-START SURGERY/IMPLANT TIMES, NUMBER OF SCREWS IMPLANTED, AND DURATION OF THE INTERVENTION BEFORE AND AFTER THE INTRODUCTION OF A DEDICATED NURSING TEAM FOR RSS. RESU

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 "PIF" FROM LEVELS T11-PELVIS ON 7/31. THE PATIENT WAS FOUND TO HAVE PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND UNDERWENT SURGERY TO REVERSE THIS. THE PATIENT WAS IMPROVING FOLLOWING INDEX THE SURGERY, BUT DEVELOPED MID BACK PAIN ALONG THE PROXIMAL ASPECT OF THE THORACOLUMBAR FUSION, WHICH WAS DIFFERENT FROM THE PATIENT'S PREOPERATIVE PAIN. THE PATIENT DENIED ANY LOWER EXTREMITY PAIN, PARESTHESIA, OR WEAKNESS, SADDLE PARESTHESIA OR BOWEL/BLADDER INCONTINENCE. ON IMAGING, THE PATIENT WAS FOUND TO HAVE A BURST FRACTURE OF T11 VERTEBRAE WITH PJK AT T10-11. THE PATIENT THEN UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN, MEDICATION REFILLS, AND SUBSEQUENTLY AN EXTENSION FROM THEIR FUSION FROM T4-T1. THORACIC KYPHOSIS MEASURED AT 76 DEGREES, LUMBAR LORDOSIS MEASURED 59 DEGREES, PELVIC INCIDENCE MEASURED TO THE 70S, AND PELVIC TILT MEASURED AT 35 DEGREES. THE BILATERAL POSTERIOR INSTRUMENTED SCREW AND ROD FIXATION WAS PRESENT FROM T11 TO THE PELVIS. THE METALLIC INTERBODY DEVICES WERE PRESENT AT L4-5, L5-6, L6-S1 WITH ANTERIOR PLATE FIXATION AT L6-S1.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: OROSZ, L. D., LEE, N. J., GUM, J. L., LEHMAN, R. A., HAGE, T. R., KATZ, J., AMELL-ANGST, T., ROY, R. T., POULTER, G. T., HAINES, C. M., JAZINI, E., GOOD, C. R. (2025). NINETY-DAY COMPLICATION AND REVISION SURGERY RATES USING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: A PROGRSS INTERIM ANALYSIS. INTERNATIONAL JOURNAL OF SPINE SURGERY, 19(4), 437¿443. HTTPS://DOI.ORG/10.14444/8777 SUMMARY: BACKGROUND: INDIVIDUALLY, ROBOTIC GUIDANCE AND 3-DIMENSIONAL NAVIGATION ASSISTANCE HAVE BEEN SHOWN TO IMPROVE SURGICAL OUTCOMES AND ACCURACY IN SPINE SURGERY. THE PAIRING OF THESE TECHNOLOGIES MAY FURTHER IMPROVE OUTCOMES; HOWEVER, DATA ARE NEEDED TO SUPPORT THIS THEORY. IN THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS), OUTCOMES WERE TRACKED FOR CASES USING A BONE-MOUNTED INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. THIS INTERIM ANALYSIS REPORTS ON 90-DAY COMPLICATIONS AND REVISIONS. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY FROM 2020 TO 2022 WERE PROSPECTIVELY ENROLLED BY 6 SURGEONS AT 4 DISTINCT CENTERS. MEDICAL, SURGICAL, AND ROBOT-RELATED COMPLICATIONS AND REVISION SURGERIES WERE COLLECTED POSTOPERATIVELY FOR UP TO 90 DAYS AND ANALYZED. RE

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, VERTEBRAL FUSION, 2 LUMBAR LEVELS. IT WAS REPORTED THAT AFTER FINISHING THE REGISTRATION, THE ARM WAS SENT TO THE PLANNED TRAJECTORIES AND IT WAS NOT ALIGNED WHAT WAS SHOWN IN THE SCREEN IN THE GUIDANCE SYSTEM VERSUS REALITY. THEY REPEATED THE PROCEDURE FROM SNAPSHOT. A NEW SNAPSHOT AND REGISTRATION (AP AND LATERAL) WERE PERFORMED AND THE EQUIPMENT WAS FINE. THEY HAD PROBLEMS FOR THE CAMERA TO MAKE THE SNAPSHOT. THE PATIENT'S NERVE ROOT WAS AFFECTED AND THIS WAS REALIZED AFTER FINISHING THE SURGERY. THE SURGICAL DELAY WAS APPROXIMATELY 1-HOUR. TRAJECTORY WAS MISALIGNED BY GREATER THAN 10 MILLIMETERS (MM). ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SNAPSHOT ISSUE WAS NOT RELATED TO THE INACCURACY/INJURY EVENT. PROBLEMS WERE ENCOUNTERED WHEN TRYING TO FIND THE POSITION OF THE NAVIGATION CAMERA TO SEE THE ROBOTIC REFERENCE FRAME AND THE SNAPSHOT FRAME AT THE SAME TIME, BUT AFTER ACHIEVING, THE NAVIGATION WAS PROPER.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD SHOWN SOME IMPROVEMENT SINCE THE SURGERY. THE SUSPECTED CAUSE WAS A PATIENT SHIFT DUE TO LEANING WHILE DRILLING, LEADING TO THE SKIVE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PAI, M., SRINIVASA, V., THIRUGNANAM, B., SONI, A., KASHYAP, A., VIDYADHARA, A., RAO, S. K. (2025). ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW FIXATION WITH CUSTOM INSTRUMENTS. CLINICAL SPINE SURGERY. HTTPS://DOI.ORG/10.1097/BSD.0000000000001841 STUDY DESIGN: PROSPECTIVE STUDY OBJECTIVE: THIS STUDY AIMS TO DESCRIBE A WORKFLOW AND CUSTOM INSTRUMENTS FOR ROBOTIC-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING THE MAZORX STEALTH EDITION. SUMMARY OF BACKGROUND DATA: POSTERIOR CERVICAL SPINAL INSTRUMENTATION USING PEDICLE SCREWS OFFERS BIOMECHANICAL ADVANTAGES BUT CARRIES RISKS OF INJURY TO THE VERTEBRAL ARTERY AND NERVE ROOTS. FLUOROSCOPIC AND NAVIGATION AIDS EXIST, YET ROBOTIC ASSISTANCE FOR CERVICAL PEDICLE SCREW PLACEMENT LACKS A DEFINED WORKFLOW. WHILE PREVIOUS GENERATIONS OF SPINE ROBOTS HAVE BEEN USED IN PLACING PEDICLE SCREWS, THERE ARE NO PAPERS IN LITERATURE THAT DESCRIBED THE USE OF THIRD-GENERATION SPINE ROBOTS IN PLACING THEM. METHODS: TWENTY-TWO PATIENTS UNDERGOING CERVICAL PEDICLE SCREW PLACEMENT WITH CUSTOM INSTRUMENTS AND ROBOTIC ASSISTANCE WERE INCLUDED. SCREW TRAJECTORIES WERE PLANNED AND EXECUTED BY THE ROBOTIC ARM, WITH POSTOPERATIVE O-ARM SCANS ASSESSING ACCURACY. CLIN

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 RIGHT L4 SCREW WAS ENTERED MEDIALLY, BREACHING THE CANAL. THIS WAS DISCOVERED AFTER A CONFIRMATION SPIN WITH A POST-OPERATIVE COMPUTED TOMOGRAPHY. THE CASE REQUIRED REVISION SURGERY, WHICH WAS PLANNED FOR THE FOLLOWING DAY. THE PATIENT WAS NOTED TO BE AFFECTED. THERE WAS NO SURGICAL DELAY TIME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO SYMPTOMS RELATED TO THE SCREW CANAL BREACH AND THE DEVIATION APPEARED TO BE ABOUT 10 MILLIMETERS (MM).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WAN, J. J., YEO, J., CHEW, Z., & DINESH, S. K. (2025). COMPARATIVE COST-EFFECTIVENESS ANALYSIS BETWEEN NAVIGATED ROBOT-ASSISTED PLATFORMS AND O-ARM NAVIGATION IN MINIMALLY INVASIVE TRANSFORAMINAL INTERBODY FUSION (MIS-TLIF). THE SPINE JOURNAL. HTTPS://DOI.OR G/10.1016/J.SPINEE.2025.05.027 SUMMARY: BACKGROUND CONTEXT: MINIMAL INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) IS AN INCREASINGLY COMMON PROCEDURE USED IN TREATING DEGENERATIVE LUMBAR SPINE CONDITIONS. ADVANCEMENT OF ROBOT-ASSISTED TECHNOLOGY HAS IMPROVED ACCURACY OF INSTRUMENTATION WITH SMALLER INCISIONS, RESULTING IN BETTER SURGICAL OUTCOMES AND SHORTER HOSPITAL STAY. PURPOSE: THIS STUDY AIMS TO ASSESS COST EFFECTIVENESS OF ROBOT-ASSISTED MINIMALLY INVASIVE TLIF(RA-TLIF) IN OUR INSTITUTION; AND COMPARE PATIENT OUTCOMES WITH CONVENTIONAL O-ARM NAVIGATED MINIMALLY INVASIVE TLIF (ON-TLIF). DESIGN: SINGLE-CENTER, RETROSPECTIVE CASE COHORT SERIES BETWEEN ELECTIVE RA-TLIF AND ON-TLIF GROUPS. PATIENT SAMPLE: ABOUT 27 PATIENTS WHO UNDERWENT ELECTIVE RA-TLIF AND CONTROL GROUP OF 50 ELECTIVE ON-TLIF. OUTCOME MEASURES: OPERATIVE DURATION, LENGTH OF INPATIENT STAY, POSTOPERATIVE AMBULATION, RATES OF INTRAOPERATIVE AND POSTOPER

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 A SPINAL SURGERY, THE PATIENT WOKE UP FEELING SOME LEFT CALF PAIN AND WENT TO URGENT CARE FOR EVALUATION. THE PATIENT UNDERWENT AN ULTRASOUND AND THE PHYSICIAN ALSO MENTIONED DECREASED BREATH SOUNDS IN THE LEFT LUNG. AS A RESULT, THE PATIENT ALSO UNDERWENT A CHEST X-RAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT AS THEY WERE DIAGNOSED WITH A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ANTICOAGULANTS AND BEGAN TO FOLLOW UP WITH THEIR HEMATOLOGIST OUTPATIENT.

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 COMPUTED TOMOGRAPHY TO FLUORO CASE FOR AN L2¿S2 OPEN PROCEDURE, ALL SCREWS DEVIATED FROM THEIR PLANNED TRAJECTORIES. THE PROCEDURE INCLUDED TITANIUM INTERBODIES PLACED FROM L2¿S1 (LATERAL CAGES) AND AN ALIF AT L5¿S1 WITH PLATES, SCREWS, AND INTERBODIES. CORTICAL TRAJECTORIES WERE USED, AND NO SKIN PRESSURE WAS NOTED. COMPUTED TOMOGRAPHY TO FLUORO REGISTRATION WAS PERFORMED USING L4 AS THE REGISTRATION LEVEL, ACHIEVING GREEN VALUES FROM L2¿S1. HOWEVER, NOTICEABLE SHIFTS WERE OBSERVED AT L2, L3, AND L4 DURING SCREW PLACEMENT. NAVIGATION ALIGNMENT WAS INCONSISTENT ACROSS ALL LEVELS, WITH THE SYSTEM SHOWING THE DRILL AS EITHER SUPERIOR OR INFERIOR, REQUIRING OCCASIONAL MANUAL ADJUSTMENT OF THE ARM GUIDE. THE SCREWDRIVER AND DRIVER EXHIBITED SIMILAR INCONSISTENCIES, WHILE THE TAP CONSISTENTLY ALIGNED WELL WITH NAVIGATION. A FINAL SNAPSHOT CONFIRMED THAT ALL SCREWS DEVIATED FROM THEIR PLANNED PATHS, APPEARING RANDOM. DUE TO ANTERIOR BREACHES, THE SURGEON REMOVED BILATERAL SCREWS AT L3 AND THE LEFT SCREW AT L5, AND SKIPPED SCREW PLACEMENT AT S2. ALL S CREWS 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 FOLLOWING A SPINAL SURGERY, THE PATIENT WAS INITIALLY DOING WELL, BUT LATER DEVELOPED PROGRESSIVELY WORSENING LOW BACK PAIN (LEFT GREATER THAN RIGHT) AND LEFT LOWER-EXTREMITY PAIN OVER SEVERAL MONTHS. SYMPTOMS INCLUDED PAIN, PARESTHESIA'S, WEAKNESS, AND OCCASIONAL SENSATION OF LEFT-SIDED FOOT DROP; NO BOWEL OR BLADDER INCONTINENCE WAS REPORTED. PAIN WAS CONSTANT TO SOME DEGREE AND WORSENED WITH PROLONGED POSITIONING, RESEMBLING SYMPTOMS PRIOR TO THE PATENT'S ORIGINAL BERTOLOTTI'S FUSION. IT WAS SUGGESTED THAT MICROMOTION AT THE LEFT BERTOLOTTI'S JOINT POSSIBLY CONTRIBUTED TO SYMPTOMS, WITH RESIDUAL HARDWARE ALSO CONSIDERED AS A POTENTIAL FACTOR. THE PATIENT UNDERWENT A LEFT-SIDED BERTOLOTTI JOINT RESECTION AND REMOVAL OF RIGHT-SIDED INSTRUMENTATION AT L6/S1.POST-OPERATIVELY, LOW BACK AND LOWER EXTREMITY SYMPTOMS RESOLVED.

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 SLIGHT DEVIATION BETWEEN THE NAVIGATION PLAN AND THE MIDAS DRILL. THE SURGEON ATTEMPTED TO INSERT A SCREW BUT FELT THAT THE AREA WAS BREACHED, LEADING TO THE DECISION TO HOLD OFF ON THE SCREW INSERTION. A NEW REGISTRATION WAS ATTEMPTED, WHICH PASSED SUCCESSFULLY, AND THE SURGEON FELT THAT NAVIGATION WAS ACCURATE FOR THE REMAINDER OF THE CASE. IT WAS NOTED THAT THE PATIENT WAS IMPACTED POST-SURGERY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAS HAD ONGOING NEUROLOGICAL ISSUES SINCE THE CASE. THE ONLY DELAY IN THE CASE WAS SWITCHING FROM CT-FLUORO TO SCAN AND PLAN REGISTRATION. THE AMOUNT OF DELAY WAS UNKNOWN. THE SURGEON STATED THE DEVIATION WAS 3 MM, HOWEVER THEY WERE COMPARING THE SCAN AND PLAN TRAJECTORY TO THE CT-FLUORO TRAJECTORY, BUT THE PLANNED TRAJECTORY WAS NOT THE SAME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SYSTEM FUNCTIONS AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SURGICAL DELAY WAS 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: CITATION: SULLIVAN, MARGARET L., ET AL. BOSTON, 2025. UNDERSTANDING TECHNICAL DIFFICULTIES AND RECOGNIZED ERRORS IN PEDIATRIC ROBOTIC SPINE SURGERY HYPOTHESIS: INTRA-OPERATIVE TECHNICAL CHALLENGES EXIST WITH ADOPTION OF ROBOTICS COUPLED WITH NAVIGATION (RCN), THESE CAN BE RECOGNIZED AND RESOLVED WITHOUT SIGNIFICANT CONSEQUENCES TO PATIENT CARE. STUDY DESIGN: LEVEL I: PROSPECTIVE MULTICENTER SURGICAL OUTCOMES REGISTRY INTRODUCTION: RCN IN POSTERIOR SPINAL FUSION IS INCREASING IN PREVALENCE, AND LITERATURE SUPPORTS ITS VALUE FOR SAFE AND ACCURATE PEDICLE SCREW PLACEMENT. THIS STUDY PRESENTS THE FIRST MULTI INSTITUTIONAL ANALYSIS OF TECHNOLOGICAL DIFFICULTIES IN PEDIATRIC ROBOTIC SPINE SURGERY. METHODS: DATA COLLECTED FROM A MULTICENTER PROSPECTIVE REGISTRY INCLUDED: PATIENT DEMOGRAPHICS, DISEASE ETIOLOGY, AND CLINICAL AND S URGICAL CHARACTERISTICS. THE DIFFICULTIES WERE CATEGORIZED AS: LOSS OF REGISTRATION, LOSS OF CALIBRATION, INABILITY TO PERFORM TRAJECTORY, SCREW MALPOSITION, AND SYSTEM MALFUNCTION. GENERALIZED E STIMATED EQUATIONS (GEE) WERE USED TO QUANTIFY RCN TECHNICAL DIFFICULTIES AND IDENTIFY ASSOCIATIONS WITH CLINICAL FACTORS AND PROCEDURAL METRICS. RESULTS: 553 PATIENTS WE

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 MEDIAL PUNCTURE ON THE RIGHT VERTEBRAE LEVEL. THE PATIENT NOW SUFFERS FOR LOWER BACK PAIN, FORWARD LEANING OF THE TRUNK, GAIT DISTURBANCE, AND HEARTBURN. THE PROCEDURE WAS COMPLETED WITH A NAVIGATION AND IMAGING SYSTEM. THERE WAS NO DELAY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS NO DEVIATION WITH THE TRAJECTORIES.

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 SCREWS WERE CORRECTLY PLACED AT L4 AND S1. HOWEVER, BOTH SCREWS PLACED AT L5 (LEFT AND RIGHT) WERE POSITIONED MORE SUPERIOR AND LATERAL THAN THE PLANNED TRAJECTORY. IT WAS SUSPECTED THAT THE SCREWS HAD ENTERED THE DISC SPACE, PROMPTING THE SURGEON TO DECIDE ON THEIR REMOVAL. IT WAS ALSO NOTED THAT THE PATIENT HAD SMALL PEDICLES AT L5. AS THE SURGEON ATTEMPTED TO REMOVE THE RIGHT L5 SCREW, THE SCREW WAS INADVERTENTLY PUSHED FURTHER IN, POTENTIALLY DEEPER INTO THE DISC SPACE. THE PATIENT BEGAN TO EXPERIENCE INTERNAL BLEEDING FROM AN UNKNOWN SOURCE. THE SURGICAL TEAM FLIPPED THE PATIENT OVER AND BEGAN EFFORTS TO STABILIZE THEM. APPROXIMATELY FIVE MINUTES AFTER SCREW REMOVAL AT L5, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP, AND THE TEAM CONTINUED WORKING TO STABILIZE THE PATIENT. ULTIMATELY, SCREWS WERE PLACED AT L4 AND S1, WHILE L5 WAS SKIPPED. A ROD WAS PLACED, RESULTING IN APPROXIMATELY A ONE-HOUR DELAY TO THE CASE. ADDITIONAL INFORMATION WAS RECEIVED. TRAJECTORIES WERE DEVIATED BETWEEN 3.5 AND 10 MILLIMETERS (MM).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN(S) PERFORMED A REVISION ON THIS PATIENT AND ALL HARDWARE WAS TO BE REPLACED. THE INFECTION WAS NOTED TO BE OSTEOMYELITIS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SONI, ABHISHEK, ET AL. ¿ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT USING A NOVEL HYBRID DILATOR TECHNIQUE: A CLINICAL SERIES OF 565 SCREWS.¿ JOURNAL OF CRANIOVERTEBRAL JUNCTION AND SPINE, VOL. 16, NO. 3, 18 SEPT. 2025, PP. 301¿306, HTTPS://DOI.ORG/1 0.4103/JCVJS.JCVJS_115_25. ABSTRACT BACKGROUND: CERVICAL PEDICLE SCREWS PROVIDE SUPERIOR BIOMECHANICAL FIXATION WITH PULLOUT STRENGTH FOUR TIMES GREATER THAN LATERAL MASS SCREWS, BUT PLACEMENT IS TECHNICALLY DEMANDING WITH TRADITIONAL MALPOSITION RATES OF 6.7%¿31.6%. ROBOTIC-ASSISTED SPINE SURGERY HAS DEMONSTRATED SUCCESS IN THORACOLUMBAR APPLICATIONS, BUT CERVICAL TRANSLATION HAS BEEN HINDERED BY THE LACK OF CERVICAL-SPECIFIC I NSTRUMENTATION REQUIRING EXPENSIVE CUSTOM INSTRUMENTS. METHODS: WE DEVELOPED A HYBRID TECHNIQUE COMBINING ROBOTIC GUIDANCE WITH STANDARD CERVICAL INSTRUMENTATION USING MINIMALLY INVASIVE SURGERY DILATORS AS AN INTERFACE. SIXTY-FIVE CONSECUTIVE PATIENTS UNDERWENT ROBOT-ASSISTED CERVICAL PEDICLE SCREW PLACEMENT WITH 565 SCREWS ACROSS C2¿C7 LEVELS USING MAZORX STEALTH ROBOTIC SYSTEM WITH O-ARM NAVIGATION. ACCURACY WAS ASSESSED USING GERTZBEIN-ROBBINS AND NEO CLASSIFICATION SYSTEMS WITH 3¿6-MONTH FOLL

Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATEL, N. A., BROWN, N. J., HE, C., PATEL, S., PENNINGTON, Z., GENDREAU, J., SAHYOUNI, R., <(>&<)> PHAM, M. H. (2025). CHARACTERIZING THE COMPLICATION PROFILE OF SPINAL ROBOTIC SYSTEMS: A MAUDE ANALYSIS OF DEVICE FAILURES AND ASSOCIATED COMPLICATIONS BY DEVICE MANUFACTURER AND BRAND NAME. JOURNAL OF CLINICAL NEUROSCIENCE, 135, 111149. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111149 INTRODUCTION: PEDICLE SCREW PLACEMENT IN SPINAL SURGERY HAS EVOLVED TO INCORPORATE INCREASED USE OF TECHNOLOGY FOR BOTH PREOPERATIVE PLANNING AND INTRAOPERATIVE GUIDANCE. IN RECENT YEARS, ROBOTIC GUIDANCE HAS BEEN USED TO INCREASE THE PRECISION, ACCURACY, AND OVERALL PATIENT SAFETY OF SPINAL COLUMN FIXATION VIA SCREW PLACEMENT. WITHIN THIS CONTEXT, THE PRESENT STUDY AIMS TO QUANTIFY AND CLASSIFY COMPLICATIONS OF SPINAL ROBOTIC DEVICES USING A NATIONALLY REPRESENTATIVE DATABASE. METHODS: THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) WAS QUERIED FOR ADVERSE EVENTS INVOLVING THE MOST WIDELY USED SPINAL ROBOTIC DEVICES FROM INCEPTION TO NOVEMBER 3RD, 2023. ENTRIES WERE TABULATED BY ASSIGNING CATEGORICAL VARIABLES BASED ON EVENT INFORMATION. RESULTS: THE QUERY YIELDED 339 UNIQUE ROBOTIC FAILURE EVEN

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, AN IMAGE GUIDED L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE MAY 19, 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. IT WAS NOTED THE PATIENT WAS DISCHARGED HOME WITH OUTPATIENT INFUSION FOR ANTIBIOTICS. THE PATIENT REPORTED A FEVER OF 100.3 AND THEIR WHITE BLOOD COUNT WAS 11.4. THERE WERE 3 LONGITUDINAL INCISIONS, 1 MIDLINE AND 1 ON EITHER SIDE OF THE SPINE. THE LEFT-SIDED INCISION HAD AN AREA ABOUT 2 CENTIMETER (CM) IN DIAMETER WITH MILD PALPABLE FLUCTUATION, SOME OVERLYING ERYTHEMA, A

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 SURGICAL TEAM USED THE GUIDANCE SYSTEM TO INSTALL THE S2 SCREW. THE L5 SCREW WAS SET UP WITH A SCREW BY USING A FREE HAND. THE S2 SCREW DISLODGED INTO THE PELVIS WHEN A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN. L5 ALSO DEVIATED, AND THE PHYSICIAN'S OPINION WAS THAT THE PATIENT'S NEUROLOGICAL SYMPTOMS AFTER SURGERY WERE CAUSED BY THE DEVIATION OF THE L5 SCREW, NOT THE S2 SCREW. THE PATIENT EXPERIENCED HEALTH DAMAGE AND THE PROCEDURE WAS EXTENDED BY LESS THAN ONE-HOUR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AS A SYMPTOM. THE TRAJECTORIES FOR THE S2 SCREW WERE DEVIATED BETWEEN 3.5 AND 10 MILLIMETERS (MM). THE TRAJECTORY DEVIATION FOR THE L5 SCREW WAS ASKED BUT UNKNOWN.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: QUICENO, E., SOLIMAN, M. A., KHAN, A., MULLIN, J. P., POLLINA, J. (2025). HOW DO ROBOTICS AND NAVIGATION FACILITATE MINIMALLY INVASIVE SPINE SURGERY? A CASE SERIES AND NARRATIVE REVIEW. NEUROSURGERY, 96(3S). HTTPS://DOI.ORG/10.1227/NEU.0000000000003352 BACKGROUND AND OBJECTIVE: IMAGE GUIDANCE HAS TRANSFORMED MINIMALLY INVASIVE SPINE SURGERY (MISS), ALLOWING FOR SAFER PROCEDURES WITHOUT EXCESSIVE BONY EXPOSURE AND REDUCING RADIATION EXPOSURE FOR THE SURGICAL TEAM. ROBOTIC PLATFORMS HAVE ENHANCED THE BENEFITS OF NAVIGATION BY PROVIDING HIGH PRECISION AND ACCURACY. HERE WE DESCRIBE A CASE SERIES TO DEMONSTRATE THE ACCURACY AND LOW COMPLICATION RATES OF REAL-TIME IMAGE-GUIDED ROBOTIC-ASSISTED (RA) MISS AT A TERTIARY REFERRAL CENTER. IN ADDITION, WE PERFORMED A NARRATIVE REVIEW ONHOW ROBOTICS AND NAVIGATION FACILITATE MISS. METHODS: A RETROSPECTIVE CHART REVIEW WAS CONDUCTED TO OBTAIN DATA FOR PATIENTS WHO UNDERWENT RA LUMBAR FUSIONS WITH REAL-TIME NAVIGATION FOR DEGENERATIVE LUMBAR PATHOLOGY BETWEEN SEPTEMBER 1, 2021, AND JANUARY 1, 2024. THE MAZOR X STEALTH EDITION (MEDTRONIC) ROBOTIC PLATFORM WAS USED. THE ACCURACY OF SCREW PLACEMENT WAS DETERMINED ACCORDING TO GERTZBEIN-ROBBINS CLAS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BIRCH, C., WELCH, N., COOK, D., HEDEQUIST, D. (2025). INSTRUMENTATION USING ROBOTICS COUPLED WITH NAVIGATION IN PEDIATRIC SP INE DEFORMITY SURGERY: A TECHNICAL REPORT OF SACROPELVIC INSTRUMENTATION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-025-01047-6. PURPOSE: THIS TECHNICAL REPORT PRESENTS THE INTRAOPERATIVE EXPERIENCE OF USING ROBOTIC ASSISTED NAVIGATION (RAN) FOR SACRO-PELVIC INSTRUMENTATION IN PEDIATRIC SPINE DEFORMITY SURGERY. METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SURGERY USING RAN FOR SACROPELVIC INSTRUMENTATION AT A SINGLE INSTITUTION FROM 2019 TO 2022 WAS CONDUCTED. IN CASES WITH SCREW CONFIRMATION IMAGING, SCREWS WERE EVALUATED USING THE GERTZBEIN AND ROBBINS CLASSIFICATION SCALE. RESULTS: 52 CASES WERE INCLUDED. AVERAGE AGE AT SURGERY WAS 14.1 YEARS AND 67.3% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSIS WAS SPONDYLOLISTHESIS (48.1%). THE AVERAGE MAJOR CURVE IN SCOLIOSIS CASES WAS 77°. A SCHANZ PIN IN THE POSTERIOR SUPERIOR ILIAC SPINE WAS PLACED IN 98.1% OF SURGERIES COMPARED TO 1 CASE WITH A SPINOUS PROCESS CLAMP. INTRAOPERATIVE 3D IMAGING SCANS (SCAN/PLAN) WERE USED FOR 69.2% OF THE ROBOTIC REGISTRATIONS TO THE PATIENT AND INTRAOPERATIV

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 CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. THE PROCEDURE BEING PERFORMED WAS AN EXPLORATION OF OCCIPUT TO C5 FUSION, REMOVAL OF HARDWARE, OCCIPUT TO C5, REVISION POSTERIOR FUSION C2-5, POSTERIOR SPINAL FUSION C6-7, T1-3, SEGMENTAL INSTRUMENTATION C3-T3, AND APPLICATION OF ALLOGRAFT BONE ON (B)(6) 2024. THE PATIENT EXPERIENCED COMPLICATIONS ON (B)(6) 2025. THE PATIENT STATED THEY EXPERIENCED WORSENING PAIN AND HARDWARE PROTRUSION 4-5 DAYS PRIOR. IT WAS NOTED THAT THE PATIENT WAS RECE