BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA 3 NAIL

    MDR report key: 2832992 · Received October 30, 2012

    Report

    Report Number
    9610622-2012-00490
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 17, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    JDS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IMPLANT SURGEON OF THE HOSPITAL REPORTED TO US THAT HE OBSERVED THAT THE NAIL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA 3 NAIL IMPLANT JDS STRYKER TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R