BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO IMPLANT

    MDR report key: 1781634 · Received July 22, 2010

    Report

    Report Number
    MW5016861
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 22, 2010
    Manufacturer
    AMENDIA
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAKO IMPLANTS BROKE DURING IMPLANTATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAKO IMPLANT MAKO IMPLANT MQP AMENDIA T617-9-28 10167
    2 MAKO IMPLANT MAKO IMPLANT MQP AMENDIA T617-9-28 10089

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other