BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X STEALTH EDITION

    MDR report key: 11864331 · Received May 21, 2021

    Report

    Report Number
    3005075696-2021-00060
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290109183213
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 BEING USED DURING A SPINAL PROCEDURE TO TREAT DEGENERATIVE DISCS WITH FIXATION USING SCREWS AND RODS. IT WAS REPORTED THAT THE RIGHT L5 SCREW WAS INFERIOR DURING A TWO LEVEL CASE. THE SCREW WAS DEVIATED BETWEEN 3.5 AND 10 MM. THE DEVIATED SCREW WAS THE LAST SCREW ON THE RIGHT AND HAD APPEARED ACCURATE ON NAVIGATION. THE SCREW WAS REMOVED AND RE-PLANNED, BUT THE SCREW FOLLOWED THE SAME HOLE. THE USE OF THE GUIDANCE SYSTEM WAS ABORTED AND THE SCREW WAS PLACED FREEHAND. THE CAUSE OF THE DEVIATION WAS NOT DETERMINED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759379 MAZOR X STEALTH EDITION OLO MAZOR ROBOTICS LTD TPL0059 07290109183213

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR