BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMMA3 NAIL

    MDR report key: 2475524 · Received February 28, 2012

    Report

    Report Number
    9610622-2012-00102
    Event Type
    Death
    Date Received
    February 28, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    OUR SALES REP REPORTED THAT AFTER A METAL EXCISION, THE PT PASSED AWAY. UNFORTUNATELY, NO FURTHER INFORMATION WAS GIVEN AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA3 NAIL IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death