BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO IMPLANT

    MDR report key: 1754293 · Received July 6, 2010

    Report

    Report Number
    MW5016649
    Event Type
    Injury
    Date Received
    July 6, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 6, 2010
    Manufacturer
    AMENDIA, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE UTILIZING IMPLANT, THE DEVICE WENT OFF TRACK. THE IMPLANT COULD NOT BE ADVANCED INTO THE DISC SPACE AND COULD NOT BE REMOVED BY THE METHOD IT WAS IMPLANTED. THE IMPLANT WAS RETRIEVED USING A RIGHT ANGLE AND CRACKED DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAKO IMPLANT MAKO IMPLANT HWC AMENDIA, INC. 10152

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability