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Death reported2025-12-09FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00029Mazor X
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
cause not established3005075696-2026-00029Medtronic plc — Surgical RoboticsMazor XRead the record ↗Death reported2025-02-25FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2025-00239Mazor X
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
cause not established3005075696-2025-00239Medtronic plc — Surgical RoboticsMazor XRead the record ↗