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