BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE BIPOLAR SYSTEM

    MDR report key: 1100428 · Received August 6, 2008

    Report

    Report Number
    1644408-2008-00247
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INITIAL SURGERY WAS SUCCESSFUL, PATIENT FELL IN 2008, DISLOCATING IMPLANT REQUIRING THIS REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BIPOLAR SYSTEM BIPOLAR KWB ENCORE MEDICAL, L.P. 265472

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 497-28-000