BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X420MM X 125°

    MDR report key: 3920943 · Received July 9, 2014

    Report

    Report Number
    0009610622-2014-00312
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    NAIL BROKE BEFORE FRACTURE FULLY HEALED. SURGEON REVISED THE PATIENT WITH A LARGER GAMMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402060 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X420MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K05E265

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention