BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 3852599 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00268
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE RETAINED BY THE SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GAMMA NAIL REMOVAL AND CONVERSION TO A RIGHT TOTAL HIP DUE A NON-UNION. UPON ATTEMPTING TO REMOVE THE GAMMA NAIL THE LAG SCREW INSERTER GEAR WAS SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332724 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention