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

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 outside of a procedure. It was reported that the client reported an issue with a screw. It was reported that this issue occurred intra op of a Transforaminal Lumbar Interbody Fusion (TLIF) L4-L5. The pedicle screws were planned correctly during the planification stage, but after reviewing the last images taken, the screws in L4-L5 Left side appeared to be shifted medially. The pedicles of the patient were small but still the Surgeon decided to place 7.5 in diameter screws. There was no delay to the procedure. The patient experienced pain/discomfort and could not move his left foot with the entire range of motion. The next day of the procedure, Surgeon removed both left side screws from the patient. Additional information was received. It was reported that the screw was deviated less than 3.5 millimeters (mm). The patient continued to have left foot weakness after the additional procedure and removal of the hardware. No additional procedures resolved the patient's pain. The patient's pedicles measured 8.5mm during planning.

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 INACCURACY DURING A T10-PELVIS FUSION (CT-FLOURO REGISTRATION). THE SCREWS AT L2 WERE MEDIAL BY ABOUT 4 MILLIMETERS (MM), BILATERALLY. THIS RESULTED IN A PATIENT INJURY, THERE WAS NERVE ROOT DAMAGE AND LOST MOTORS BILATERALLY. THE INACCURACY WAS NOTICED DURING A POST OP SPIN. THE SCREWS WERE PLANNED AT 18 DEGREES OF ANGULATION, A SCHANZ PIN WAS USED, AND THERE WAS NOTABLE SOFT TISSUE PRESSURE.

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 TLIF PROCEDURE FROM L4-S1, THE SCHANZ ARM AND SCREW WERE USED TO AFFIX THE ROBOT TO THE PSIS. THE REGISTRATION WAS PERFORMED. RETRACTORS WERE REMOVED PRIOR TO THE SCAN AND REINTRODUCED BEFORE INSTRUMENTATION. THE SURGEON NOTICED THE INACCURACY WITH THE ROBOTIC TRAJECTORY NOTING THE DEVIATIONS ON L5 VERTABRAE WERE BOTH MEDIAL TOWARDS SPINAL CANAL. THE DEVIATION WAS OVER 5 MM AND BETWEEN 3.5-10 MILLIMETERS (MM). THE VERTEBRAL WALLS WERE BREACHED AND A DURAL TEAR OCCURRED. THE SURGEON TOOK CORRECTIVE ACTION AND REPAIRED THE DURAL TEAR. THE GUIDANCE SYSTEM WAS ABORTED AND NAVIGATION WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. UPON FOLLOW-UP WITH SURGEON, PATIENT NOW COMPLAINED OF RIGHT LEG PAIN.

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 IMAGE TRANSFER ISSUE AND MISPOSITIONED SCREWS. THE SCAN WAS ON AN EXTERNAL FLASH DRIVE, BUT THE GUIDANCE SYSTEM DID NOT IMPORT THE SCAN, AS IT INDICATED THAT THE PATIENT SCAN ALREADY EXISTED. THE SCAN DID NOT SHOW UP ON THE SYSTEM. WHEN READING THE EXTERNAL DRIVE IN THE IMPORT SCREEN, THE SYSTEM SEARCHED FOR OVER TEN MINUTES. THE SYSTEM WAS SOFT REBOOTED, AND THE THE SITE HAD TO COMPLETE A NEW SCAN AND PLAN AND 3DEFINE SHOT. ALL FILES WERE DELETED OFF THE ZIP DRIVE AND ANOTHER SCAN WAS PERFORMED ON THE PATIENT. THE SCAN WAS RENAMED TO BE THE PATIENT'S INITIALS WITH A ZERO TO INSURE THE CORRECT SCAN WAS TRANSFERRED. THE SCAN WAS ACCEPTED, AND THE SITE WAS ABLE TO PLAN SCREWS. SCREWS ON LEFT SIDE OF PATIENT WERE PLACED FIRST. DURING RIGHT SCREW PLACEMENT, ABNORMAL BLEEDING WAS OBSERVED. BLOOD WAS COMING OUT FROM THEM CANNULA. THIS CAUSED THE SURGICAL TEAM TO TAKE AN X-RAY AND THEY NOTICED THAT SCREWS ON LEFT SIDE HAD BEEN PLACED INACCURATELY. THE SITE REMOVED THE ROBOT FROM BED AND PROCEEDED TO PLACING SCREWS WITH NAVIGATION. SCANS WERE RETAKEN. THE PROCE

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 used during a sacroiliac and thoracolumbar procedure. It was reported that there was a deviated screw. The implants from the SI fusion appeared to be out of place. It was noted that the patient was affected The patient went in for a follow up when this was noticed. There was no reported delay to the procedure.

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 L4 SCREW WAS MEDIALLY DEVIATED (+/- 3 MILLIMETERS (MM)) RELATIVE TO THE PLANNED TRAJECTORY. PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY USING THE NAVIGATION SYSTEM AND IMAGING SYSTEM. THERE WAS NO DELAY TO THE PROCEDURE. THE PATIENT EXPERIENCED PAIN AFTER SURGERY.

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 THERE WAS NO ISSUE WITH THE DRILL ITSELF. THE 3DEFINE, THE SNAPSHOT, AND THE FUSION OF THE FLUOROSCOPY IMAGES WITH THE PREOPERATIVE CT WAS CARRIED OUT AS USUAL. THE FUSION APPEARED ACCURATE, AND THEY PROCEEDED WITH THE SURGERY. THE SCREWS ON THE RIGHT SIDE WERE CORRECTLY PLACED, EXACTLY AS PLANNED USING THE NAVIGATION THAT ALSO APPEARED TO BE CORRECT. THE PROBLEM STARTED WITH THE LEFT SIDE. ALTHOUGH THE NAVIGATION STILL APPEARED TO BE CORRECT, WHEN THE DRILL WAS USED, THE PATIENT'S LEG SUDDENLY MOVED (JERKED), AND THE NEUROPHYSIOLOGIST OBSERVED THAT THE NERVE ROOT HAD BEEN AFFECTED. THEY RE-CHECKED THE SURGICAL PLAN AGAIN IN CASE THEY HAD MADE A MISTAKE, BUT IT WAS CORRECT. THE POTENTIALS OF THE LEFT L4 NERVE ROOT DROPPED BY MORE THAN 50 PERCENT WHEN THE DRILL WAS USED DURING THE SURGERY. WHEN THE PATIENT WOKE UP, NO NEUROLOGICAL DEFICITS WERE APPRECIATED. TWO DAYS AFTER, THE SURGEON CONFIRMED THAT THE PATIENT WAS OK. THE DELAY WAS MORE THAN 40 MINUTES.

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 USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A NEURO MONITORING ISSUE AND ACCURACY ISSUE. REGISTRATION OF THE TWO THORACIC LEVELS (T5¿T6) WAS UNSUCCESSFUL. THE PROCEDURE WAS THEREFORE CONTINUED USING NAVIGATION, AND PEDICLE SCREWS AT THESE LEVELS WERE PLACED WITH THE NAVIGATION SYSTEM. AN INTRAOPERATIVE THREE-DIMENSIONAL (3D SCAN WAS PERFORMED, WHICH IDENTIFIED THE LEFT-SIDED T7 SCREW AS BEING MEDIALLY POSITIONED. THE SURGEON SUBSEQUENTLY REMOVED THE SCREW. THIS ISSUE WAS IDENTIFIED POST-OPERATIVELY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 30 MINUTES. REDUCED RESPONSE WAS NOTED ON THE PATIENT'S LEFT SIDE.

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 DRILLING ON THE RIGHT SIDE OF L2, BACKING OCCURRED. AFTERWARDS, THE PHYSICIAN DECIDED TO CONTINUE. THEY LEFT THE SITE AT THAT TIME. IN THE EVENING ON MARCH 25, THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THERE WAS A POSSIBILITY THAT THE ROOT WAS TOUCHED DURING DRILLING RATHER THAN BACKING AT SFDC. IN THE MORNING OF MARCH 26, THE PHYSICIAN FROM SPINE VISITED AND SAID THAT THE PATIENT HAD LOWER LIMB SYMPTOMS AND THAT THEY WOULD CONDUCT A DETAILED EXAMINATION. THERE WAS LESS THAN AN HOUR DELAY. IMPACT ON PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE NERVE WAS DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AFTER THE EVENT, NORMAL OPERATION OF THE GUIDANCE SYSTEM WAS CONFIRMED.

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 PROCEDURE WAS COMPLETED IN TWO SEGMENTS. THE SURGEON CREATED THE PLANNING INDEPENDENTLY AND INDICATED THAT THE TRAJECTORIES PROVIDED WERE MORE MEDIAL THAN IF THEY WERE TO FREEHAND, BUT CHOSE TO EXECUTE THE PLAN. T9-L1 SEGMENT WAS PERFORMED WITHOUT ISSUE. DURING THE SECOND SEGMENT, T4-T8, ALL SCREW ON THE LEFT WERE COMPLETED WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE RECOMMENDED A REFERENCE FRAME ON A SPINOUS PROCESS CLAMP FOR NAVIGATIONAL ACCURACY, BUT THE SURGEON REFUSED CITING SPACE IN THE OPERATIVE FIELD. RIGHT T8 WAS EXECUTED WITHOUT AN ISSUE, BUT DURING RIGHT T6, THE SURGEON REPORTED A POSSIBLE COLLISION BETWEEN SCREW AND MOUNT, BUT ACCURACY WAS CONFIRMED. AT RIGHT T4, THERE WAS AN AUDIBLE CHANGE IN PITCH INDICATING THAT THE DRILL HAD EXITED AND RE-ENTERED THE CORTICAL BONE DURING DRILLING. WHEN THE DRILL WAS REMOVED A SIGNIFICANT CSF LEAK WAS OBSERVED. THE GUIDANCE SYSTEM WAS UNMOUNTED AND A SCAN SHOWED THAT RIGHT T4 AND T6 WERE MEDIAL. THESE SCREWS WERE REPLACED WITH NAVIGATION. A MOTOR CHECK FOUND WEAKNESS TO THE RIGHT SIDE, REQUIRING INCREASED STIMU

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWENTY SIX PATIENTS UNDERWENT A SPINAL PROCEDURE TO ADDRESS SCOLIOSIS AND/OR KYPHOSIS OF MORE THAN FOUR SEGMENTS. IT WAS NOTED THAT TWENTY EIGHT SCREWS WERE BREACHED LESS THAN TWO MILLIMETERS(GRADE B), NINE SCREWS BREACHED TWO TO FOUR MILLIMETERS(GRADE C), TWO SCREWS BREACHED FOUR TO SIX MILLIMETERS(GRADE D), AND TWO SCREWS BREACHED GREATER THAN SIX MILLIMETERS(GRADE E). THIRTEEN SCREWS WERE CONSIDERED CLINICALLY SIGNIFICANT. IN REGARDS TO PATIENTS, FIFTEEN PATIENTS HAD A GRADE B BREACH, NINE PATIENTS HAD A GRADE C TO E BREACH, AND THREE PATIENTS HAD A GRADE D TO E BREACH. SIX PATIENTS EXPERIENCED A WOUND INFECTION, ONE PATIENT HAD AN IMPLANT RELATED COMPLICATION, AND ONE PATIENT HAD AN ADJACENT SEGMENT PATHOLOGY. THERE WERE THREE PATIENTS WITH DURAL TEARS, WHICH WERE REPAIRED DURING THE INITIAL SURGERY. THERE WERE NINE PATIENTS THAT REQUIRED A REVISION SURGERY. ONE WAS SCREW RELATED ISSUE, ONE WAS DUE TO AN IMPLANT FAILURE, SIX WERE DUE TO INFECTION RELATED COMPLICATIONS, AND ONE WAS DUE TO THE ADJACENT SEGMENT.

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 SCREWS WERE IMPLANTED WITH A FULL SPEED DRILL, TAPPING, AND THEN SCREW PLACEMENT. IN COME SITUATIONS THE SURGEON PREPARED THE ENTRY POINT BY REMOVING BONE. LEFT SIDE SCREWS WERE OPERATED ON THE LEFT SIDE OF THE PATIENT, AND ON THE RIGHT SIDE OF THE PATIENT FOR RIGHT SCREWS. IT WAS NOTED THAT T3 RIGHT DEVIATED MEDIALLY.

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 AT S2-T3, SEVEN SCREWS WERE MISPLACED TOWARDS THE SPINAL CANAL. SIX SCREWS WERE ON THE RIGHT AND ONE WAS ON THE LEFT. THERE WERE FIVE REGISTRATIONS IN THE CT TO FLUORO WORKFLOW, AS THERE WERE FIVE SEGMENTS. AFTER S2 THERE WAS AN ANATOMY SHIFT, SO RE-REGISTRATION WAS NEEDED. OTHERWISE, ALL LEVELS WERE GREEN WITH THE EXCEPTION OF ONE, WHICH WAS BELIEVED TO BE T6. THE NAVIGATION WAS ACCURATE. THE MISPLACED SCREWS WERE REMOVED AND REPLACED USING A NAVIGATION SYSTEM. THE PATIENT HAS EXPERIENCED TRANSIENT WEAKNESS IN THE HIP, WHICH AS RESOLVED. THE DELAY WAS AROUND AN HOUR. THE DEVIATION WAS 3MM.

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 PROCEDURE WAS A SPINE PROCEDURE. IT WAS NOTED THAT THERE WAS ONE CASE WITH A SCREW PLACEMENT DEVIATION, AND ANOTHER CASE FROM ANOTHER DAY, WHERE REGISTRATION OF THE SECOND SEGMENT WAS NOT SUCCESSFUL AND SURGERY WAS COMPLETED WITHOUT THE USE OF 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: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SCREWS WERE REMOVED AFTER THE FAULTY POSITION WAS SEEN INTRA-OPERATIVELY AND WERE NOT SEEN ON POST-OPERATIVE THREE-DIMENSIONAL (3D) SCANS. THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE 10-15MM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN 82-YEAR-OLD FEMALE UNDERWENT PLANNED THORACIC PERCUTANEOUS INSTRUMENTATION FOR AN UNSTABLE T5 FRACTURE USING ROBOTIC NAVIGATION. DURING THE PROCEDURE, ROBOTIC REGISTRATION WAS PROLONGED AND TECHNICALLY CHALLENGING. DURING PEDICLE SCREW PLACEMENT, LOSS OF RESISTANCE WITH CSF RETURN WAS NOTED AND INSTRUMENTATION WAS STOPPED. SHORTLY THEREAFTER, NEUROMONITORING SIGNALS WERE LOST, AND THE PATIENT EXPERIENCED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WITH RAPID RETURN OF SPONTANEOUS CIRCULATION FOLLOWING BRIEF RESUSCITATION. POST-EVENT EVALUATION DEMONSTRATED ACUTE MYOCARDIAL DYSFUNCTION WITH PATENT CORONARY ARTERIES AND IMAGING FINDINGS CONCERNING FOR THORACIC SPINAL CORD INJURY RELATED TO A MEDIAL PEDICLE BREACH. THE FOLLOWING DAY, THE SERVICE RECEIVED AN URGENT MANUFACTURER SAFETY NOTICE REGARDING ROBOTIC NAVIGATION SOFTWARE ACCURACY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: KERAUDY, A., DE BUCK, P., HAETTEL, P., GHANNAM, B., ASSAKER, R., LEROY, H.-A. (2026). 2-STAGED ROBOT-ASSISTED VERTEBRECTOMY FOR METASTATIC LUMBAR SPINE LESION: A PROOF-OF-CONCEPT CASE. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1007/S00586-025-09713-Z SUMMARY: PURPOSE: SPINAL METASTASES FROM TESTICULAR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) ARE EXTREMELY RARE AND MAY REQUIRE COMPLEX SURGICAL STRATEGIES. THIS CASE AIMS TO ILLUSTRATE THE ROLE OF ROBOT-ASSISTED SPINE SURGERY (RASS) IN ACHIEVING ONCOLOGICAL RESECTION AND SPINAL STABILIZATION IN THE CONTEXT OF VERTEBRAL INVASION. METHODS: A 33-YEAR-OLD MALE WITH METASTATIC NSGCT PRESENTED WITH LOCALIZED L3 VERTEBRAL INVOLVEMENT. A TWO-STAGE SURGICAL APPROACH WAS PERFORMED. THE FIRST STAGE INVOLVED POSTERIOR DECOMPRESSION AND VERTEBRAL RESECTION. PEDICLE SCREW PLACEMENTS AND OSTEOTOMIES WERE PERFORMED UNDER ROBOT-ASSISTED GUIDANCE. THE SECOND STAGE CONSISTED OF ANTERIOR TUMOR AND VERTEBRAL BODY RESECTION VIA LAPAROTOMY, FOLLOWED BY EXPANDABLE TITANIUM CAGE PLACEMENT. RESULTS: COMPLETE VERTEBRECTOMY AND TUMOR RESECTION WERE ACHIEVED WITH NO POSTOPERATIVE NEUROLOGICAL DEFICITS. THE ROBOT-ASSISTED TECHNIQUE ALLOWED PRECISE EXECUTION OF

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., POULTER, G. T., HAINES, C. M., LEE, N. J., RAFIQZAD, Y., LEREBO, W. T., ROY, R. T., JAZINI, E., GUM, J. L., LEHMAN, R. A., GOOD, C. R. (2026). COMPREHENSIVE OUTCOMES FOLLOWING NAVIGATED ROBOTICS IN THORACOLUMBAR SPINE SURGERY: THE PROGRSS FINAL ANALYSIS. GLOBAL SPINE JOURNAL. HTTPS://DOI.ORG/10.1177/21925682261421190 SUMMARY STUDY DESIGN: PROSPECTIVE MULTICENTER COHORT STUDY. OBJECTIVES: INTEGRATION OF ROBOTIC GUIDANCE WITH NAVIGATION REPRESENTS A NATURAL EVOLUTION IN SPINE SURGERY TECHNOLOGIES. BOTH MODALITIES HAVE INDEPENDENTLY DEMONSTRATED IMPROVED IMPLANT ACCURACY, REDUCED RADIATION EXPOSURE, AND EXPANDED MINIMALLY INVASIVE CAPABILITIES, YET DATA ON INTEGRATED PLATFORMS REMAIN LIMITED. THE PROSPECTIVE ROBOTIC-GUIDED REGISTRY OF SPINE SURGERY (PROGRSS) EVALUATES SURGICAL, CLINICAL, AND PATIENT-REPORTED OUTCOMES ACROSS A BROAD RANGE OF PROCEDURES PERFORMED WITH AN INTEGRATED ROBOTIC-ASSISTED NAVIGATION SYSTEM. METHODS: ADULTS UNDERGOING NAVIGATED ROBOTIC THORACOLUMBAR SURGERY BETWEEN 2020 AND 2024 WERE ENROLLED BY SIX SURGEONS ACROSS FOUR CENTERS. DEMOGRAPHIC, SURGICAL, AND ROBOT-RELATED METRICS WERE COLLECTED. PATIENT-REPORTED OUTCOMES INCLUDED ODI AND PROMIS GLOBA

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: HTTP://DX.DOI.ORG/10.1590/S1808-185120262501303235. SUMMARY: OBJECTIVE: TO ANALYZE THE LIMITATIONS AND COMPLICATIONS OF USING A ROBOTIC SYSTEM IN SPINAL SURGERIES DURING THE LEARNING CURVE. METHODS: TO EVALUATE THE RESULTS OF THE APPLICATION OF 415 PEDICLE SCREWS IN 67 PATIENTS UNDERGOING SPINAL SURGERY IN WHICH THE ROBOTIC SYSTEM WAS USED. RECORDING TIME, FLUOROSCOPY TIME, INTRAOPERATIVE RADIATION DOSE, IMPLANT ACCURACY, ABANDONMENT OF THE ROBOTIC SYSTEM, PROBLEMS WITH THE SYSTEM PROGRAM, AND CLINICAL COMPLICATIONS WERE EVALUATED. RESULTS: DISCREPANT VALUES WERE OBSERVED IN RECORDING TIME IN 9 (13.43%) PATIENTS, IN FLUOROSCOPY TIME IN 3 (4.47%), AND IN INTRAOPERATIVE RADIATION DOSE IN 8 (11.94%). MALPOSITIONING (VERTEBRAL PEDICLE WALL RUPTURE > 2 MM) OCCURRED IN 3.5% OF THE IMPLANTS EVALUATED IN THE AXIAL PLANE AND 0.48% IN THE SAGITTAL PLANE. NO ABANDONMENT OF THE ROBOTIC SYSTEM WAS OBSERVED. NEUROLOGICAL DEFICIT WAS OBSERVED IN ONE PATIENT. CONCLUSIONS: THE ROBOTIC SYSTEM DEMONSTRATED EFFECTIVENESS AND PRECISION IN IMPLANT PLACEMENT, BUT SYSTEM LIMITATIONS WERE OBSERVED, MAINLY RELATED TO THE ACQUISITION OF GOOD-QUALITY IMAGES FOR SYSTEM REGISTRATION. LEVEL OF EVIDENCE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AURON, M., BARKAY, G., EINAV, O., LANIADO, D., WEIL, Y., SCHROEDER, J. E. (2026). ROBOTIC-ASSISTED VERSUS FLUOROSCOPY-GUIDED SACROILIAC SCREW FIXATION: A RETROSPECTIVE COMPARATIVE STUDY. INJURY, 57(3), 113019. HTTPS://DOI.ORG/10.1016/J.INJURY.2026.113019 BACKGROUND: PERCUTANEOUS SACROILIAC (SI) SCREW FIXATION IS A WIDELY USED TECHNIQUE FOR STABILIZING SACRAL FRACTURES BUT IS CONSIDERED TECHNICALLY DEMANDING DUE TO COMPLEX PELVIC ANATOMY AND PROXIMITY TO NEUROVASCULAR STRUCTURES. CONVENTIONAL FLUOROSCOPY-GUIDED METHODS ARE ASSOCIATED WITH A RELATIVELY HIGH RISK OF SCREW MISPLACEMENT AND CONSIDERABLE RADIATION EXPOSURE TO PATIENTS AND STAFF. ROBOTIC-ASSISTED NAVIGATION SYSTEMS HAVE BEEN INTRODUCED TO ENHANCE SCREW ACCURACY AND REDUCE RADIATION EXPOSURE. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICIENCY, SAFETY, AND ACCURACY OF SACROILIAC SCREW FIXATION USING A ROBOT-ASSISTED METHOD COMPARED WITH A CONVENTIONAL FREEHAND TECHNIQUE. METHODS: MEDICAL RECORDS OF PATIENTS TREATED WITH SACROILIAC SCREW FIXATION FOR SACRAL FRACTURES AT A SINGLE LEVEL 1 TRAUMA CENTER BETWEEN DECEMBER 2014 AND AUGUST 2025 WERE RETROSPECTIVELY ANALYZED. PATIENTS WERE DIVIDED INTO ROBOTIC-ASSISTED AND FREEHAND

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 — 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.