BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL LATERAL FIBULA PLATE, 5 HOLE

    MDR report key: 4120520 · Received September 26, 2014

    Report

    Report Number
    0008010177-2014-00273
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K081284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. NO EVALUATION OF THE DEVICE WILL BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING PRIMARY SURGERY FOR A FIBULA FRACTURE SURGEON WAS PUTTING ON A VARIAX LOCKING PLATE AND THREE OF THE HOLES WOULD NOT ACCEPT LOCKING SCREWS. SURGEON WAS A LITTLE FRUSTRATED, BUT EVENTUALLY GOT A FEW TO WORK AND CONTINUED WITH THE SURGERY. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600996 DISTAL LATERAL FIBULA PLATE, 5 HOLE PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other