BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, TI GAMMA3® Ø10.5X100MM

    MDR report key: 3920959 · Received July 9, 2014

    Report

    Report Number
    0009610622-2014-00313
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    AFTER GAMMA3 SURGERY, IT WAS FOUND THAT THE LAG SCREW CUT. PATIENT WAS REVISED TO A BHA. THIS CASE WAS PRESENTED AT THE SYMPOSIUM ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401140 LAG SCREW, TI GAMMA3® Ø10.5X100MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention