BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDLOCK IMPLANT

    MDR report key: 2792179 · Received October 11, 2012

    Report

    Report Number
    3006524618-2012-00816
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR WOULD NOT DETACH. AFTER TENSIONING, THE BULLET PIN GOT PUSHED PAST THE CROSSBAR AND WOULD NOT BREAK OFF. THE DOCTOR HAD TO USE A MALLET TO BREAK OFF THE ANCHOR AND REMOVE IT FROM THE BONE. THE SURGEON THEN DRILLED A NEW BONE HOLE AND PLACED A NEW ANCHOR IN PLACE. THE REPAIR WAS COMPLETED AND NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDLOCK IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT MBI ARTHROCARE CORPORATION 1020488

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention