Mazor X — Death 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'S TECHNIQUE WAS DRILL, TAP, THEN SCREW. THE SURGEON OPERATED AND STARTED ON THE RIGHT SIDE. T3 AND T4 WERE PLACED WHEN AN INACCURACY WAS NOTICED. IT WAS ALSO NOTED THAT WITH REGISTRATION AND AFTER RE-IMAGING, THEY HAD A YELLOW VALUE BUT THEY WERE UNSURE WHAT LEVEL THIS WAS ON. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A PRE-EXISTING FRACTURE AT T5.

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

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

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