BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABRAFIX SPEEDLOCK PLUS IMPLANT SET WITH MAGNU

    MDR report key: 2822971 · Received October 23, 2012

    Report

    Report Number
    3006524618-2012-00839
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A LATERAL RELEASE OF THE KNEE, THE ANCHOR WOULD NOT DISENGAGE. PROCEDURE WAS COMPLETED USING A COMPETITOR'S DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LABRAFIX SPEEDLOCK PLUS IMPLANT SET WITH MAGNU FASTENER, FIXATION, NONDEGRADABLE, SOFT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other