BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAGNUM KNOTLESS IMPLANT

    MDR report key: 4180269 · Received October 15, 2014

    Report

    Report Number
    3006524618-2014-00304
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K042584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A MINIMAGNUM KNOTLESS IMPLANT, THE IMPLANT DID NOT DEPLOY PROPERLY. THE IMPLANT WAS REMOVED FROM THE BONE AND A NEW BONE HOLE WAS DRILLED TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653741 MINIMAGNUM KNOTLESS IMPLANT FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORPORATION 1032855

    Patients

    Seq Age Sex Outcome Treatment
    1 Other