BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM X

    MDR report key: 3905110 · Received May 29, 2014

    Report

    Report Number
    3006524618-2014-00164
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K081497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING MAGNUM X IMPLANT, THE IMPLANT FAILED TO LOCK AFTER IT WAS SUCCESSFULLY DEPLOYED INTO THE BONE. THE IMPLANT WAS ABANDONED IN THE BONE AND THE SURGEON DRILLED A NEW BONE HOLE TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317474 MAGNUM X FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1046256

    Patients

    Seq Age Sex Outcome Treatment
    1 Other