BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA NAIL

    MDR report key: 8367291 · Received February 25, 2019

    Report

    Report Number
    0009610622-2019-00081
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    November 27, 2018
    Report Date
    February 25, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THIS PI IS FOR THE REVISION OF A GAMMA NAIL ON PATIENT'S RIGHT SIDE. IN PROVIDING ADDITIONAL INFORMATION FOR A REVISION OF THE PATIENT'S RIGHT TOTAL KNEE, AND A REVISION OF A T2 SCN NAIL PRIOR TO THAT, REP REPORTED THE FOLLOWING: "THIS PATIENT ALSO HAD A GAMMA NAIL INSERTED AND EX-PLANTED ON THE RIGHT SIDE PRIOR TO HAVING THE T2 SCN NAIL PUT IN AND EX-PLANTED. HOWEVER, I DO NOT HAVE THESE DATES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160570 UNKNOWN GAMMA NAIL IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention