BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAZOR X SYSTEM

    MDR report key: 24148391 · Received January 22, 2026

    Report

    Report Number
    3005075696-2026-00029
    Event Type
    Death
    Date Received
    January 22, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 22, 2026
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE ARTICLE. B2) DATE OF DEATH(S) WERE NOT PROVIDED. THE DATE ENTERED IS THE ACCEPTED PUBLICATION DATE OF THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE ACCEPTED PUBLICATION DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    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 DEATHS ASSOCIATED WITH THE MX, COMPARED TO ZERO DEATHS WITH THE MXSE. CONCLUSION: WHILE THE MAUDE DATABASE CANNOT BE USED TO CALCULATE THE INCIDENCE OR PREVALENCE OF ADVERSE EVENTS, IT PROVIDES INSIGHT INTO THE TYPES OF ADVERSE EVENTS THAT TEND TO OCCUR WITH MEDICAL DEVICES. MAUDE REPORTS SUGGEST THAT USER RELATED ERRORS ACCOUNT FOR MOST OF THE ADVERSE EVENTS THAT OCCUR, UNDERSCORING THE NEED FOR FOCUSED SURGEON TRAINING. OUR STUDY HIGHLIGHTS THE IMPORTANCE OF UNDERSTANDING BOTH THE TYPES OF ADVERSE EVENTS AND THEIR ROOT CAUSES TO PROMOTE PATIENT SAFETY AND REDUCE COMPLICATION RATES. REPORTED EVENTS: 202 DEVIATION EVENTS WERE IDENTIFIED. IN ADDITION, THERE WERE REGISTRATION ERRORS, MACHINE MALFUNCTIONS, SPONTANEOUS RESTARTS, AND SYSTEM ERRORS. IT WAS REPORTED THAT THE MOST COMMON ADVERSE PATIENT OUTCOME WERE MOTOR DEFICITS. ADDITIONALLY, 12% OF EVENTS REQUIRED REVISION SURGERY AND 38% HAD ABORTION OF THE SYSTEM. ROOT CAUSES OF THE DEVIATIONS, REGISTRATION ERROR, SYSTEM ERROR, NAVIGATION ERROR, AND MACHINE HARDWARE DEFECTS WERE ATTRIBUTED TO ANATOMY, SOFT TISSUE PRESSURE, USER ERROR, EXTERNAL MACHINE ERRORS, PATIENT SHIFTS, WORKSTATION ISSUES, 3D PLANNING SOFTWARE ISSUE, APPLICATION ISSUE, SURGICAL ARM ISSUES, 3DEFINE CAMERA ISSUE, CT-FLUORO REGISTRATION, AND NAVIGATION. THERE WERE 2 DEATHS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206374 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death