BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 11891169 · Received May 26, 2021

    Report

    Report Number
    3005075696-2021-00065
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109181158
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM. IT WAS REPORTED THAT EVERY TIME THE SURGEON USED THE GUIDANCE SYSTEM AND THEY COULD REGISTER THE PATIENT PROPERLY, 1 OR 2 SCREWS HAD TO BE MANUALLY CORRECTED. THE SURGEON MENTIONED THAT AFTER A 1.5 HOUR DELAY, THEY USUALLY BROUGHT IN THE C-ARM TO FINISH THE CASE. THE SURGEON MENTIONED THAT NOT BEING ABLE TO USE TROCARS MADE C-ARM GUIDANCE MORE DIFFICULT. THE SURGEON DID NOT KNOW HOW MANY CASES THIS ISSUE HAD OCCURRED IN. THERE WAS NO PATIENT HARM AND THE PROCEDURE WERE DELAYED OVER AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787039 MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290109181158

    Patients

    Seq Age Sex Outcome Treatment
    1