BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW, T10 FULL THREAD, 2.7MM/L18MM

    MDR report key: 4151222 · Received October 8, 2014

    Report

    Report Number
    0008031020-2014-00472
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K132502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE SURGEON WANTED TO USE THE 2.7 SCREW. HE PUT IT IN AND THOUGHT THAT IT DIDN¿T GET A HOLD OF THE BONE AS WELL AS HE WOULD HAVE LIKED. SURGEON TOOK OUT THE 2.7 SCREW AND PUT IN THE 3.5 SCREW AND IT GOT A BETTER HOLD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632988 BONE SCREW, T10 FULL THREAD, 2.7MM/L18MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other