BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO MEMORY STAPLE

    MDR report key: 956799 · Received November 29, 2007

    Report

    Report Number
    1833506-2007-00001
    Event Type
    Malfunction
    Date Received
    November 29, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 18, 2007
    Manufacturer
    BIOPRO, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILURE APPEARED TO BE CAUSED BY FATIGUE STRESSES. THE ACTUAL TIME OF STAPLE FRACTURE WAS NOT DETERMINED. THIS COULD HAVE BEEN CAUSED BY PT NON-COMPLIANCE. FATIGUE FAILURE COULD NOT OCCUR UNLESS THE DEVICE WAS BEING STRESSED IN A MANNER THAT WOULD NOT HAPPEN IF PROPER POST OPERATIVE SPLINTING AND COMPLIANCE WAS FOLLOWED.

    Description of Event or Problem · 1

    SEVEN MONTHS POST-OPERATIVE THE STAPLE BROKE AND HAD TO BE REMOVED. IT APPEARS THAT THE FUSION WAS HEALED BEFORE THE STAPLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO MEMORY STAPLE STAPLE GDW BIOPRO, INC. 105678

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention