BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, STST 11X180MM X 125

    MDR report key: 2221528 · Received August 11, 2011

    Report

    Report Number
    9610622-2011-00369
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RISK MANAGER AT THE HOSPITAL, REPORTED THAT THE DEVICE FRACTURED AND THE PT UNDERWENT FOR AN UNANTICIPATED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, STST 11X180MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K128577

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention