BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 125°

    MDR report key: 4123973 · Received September 27, 2014

    Report

    Report Number
    0009610622-2014-00522
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    May 7, 2013
    Report Date
    September 5, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    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. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, GAMMA3 SURGERY WAS PERFORMED. NAIL BREAKAGE WAS FOUND DUE TO NONUNION. ON (B)(6) 2013, REVISION SURGERY WAS PERFORMED. THIS CASE WAS PRESENTED AT THE MEETING OF JAPANESE SOCIETY FOR FRACTURE REPAIR ON 6/28/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603831 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K550506

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention