BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR PROSTHESIS

    MDR report key: 940939 · Received November 8, 2007

    Report

    Report Number
    9612771-2007-00049
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    October 31, 2002
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "RETROSPECTIVE ONE-TIME SUMMARY REPORT". THIS REPORT COVERS A TOTAL OF ONE (1) SERIOUS INJURY MDR. THE REASON THE FOREIGN-SOURCE MDR REPORTABLE EVENTS (BEING SUBMITTED UNDER EXEMPTION) ARE BEING FILED LATE IS DUE TO A MISUNDERSTANDING BY THE MANUFACTURER, PLUS ORTHOPEDICS AG, OF THE MDR REQUIREMENTS APPLICABLE TO FOREIGN MANUFACTURERS. AT THE TIME OF THESE EVENTS PLUS ORTHOPEDICS AG ERRONEOUSLY BELIEVED THAT FOREIGN EVENTS WERE REPORTABLE ONLY IF THE EVENT INVOLVED A DEVICE FROM THE "SAME LOT" AS DEVICES THAT WERE DISTRIBUTED IN THE UNITED STATES. THUS THE MDR'S THAT ARE THE SUBJECT OF THIS RETROSPECTIVE ONE-TIME SUMMARY REPORT WERE NOT APPROPRIATELY EVALUATED FOR MDR REPORTABILITY, AND NOT REPORTED TO FDA. APPROPRIATE CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A LOCKED BIPOLAR HEAD WAS REPORTED IN A CASE IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR PROSTHESIS KWY PLUS ORTHOPEDICS AG 16762 0110.02.3030

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention