BEUDAMED
    FDA Adverse Event Other Summary report: N

    NI

    MDR report key: 644221 · Received November 1, 2005

    Report

    Report Number
    2086141-2005-00007
    Event Type
    Other
    Date Received
    November 1, 2005
    Date of Event
    July 25, 2004
    Report Date
    October 5, 2005
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PLUS ORTHOPEDICS HAS JUST BEEN INFORMED OF A PREVIOUSLY UNREPORTED REVISION SURGERY THAT TOOK PLACE IN 2004 CONCERNING AN UNSPECIFIED DEVICE PROBLEM. INFO PERTAINING TO ANY EXPLANTED DEVICE, DEVICE FAILURE, OR THE CONDITION REQUIRING REVISION SURGERY HAS NOT BEEN COMMUNICATED TO PLUS. AND DEVICE DETAILS CANNOT BE FOUND WITH THE INFO REPORTED TO PLUS THUS FAR. PLUS WAS INFORMED OF THE REVISION SURGERY VIA LEGAL REPRESENTATION AFTER A LAWSUIT WAS FILED AGAINST PLUS ALLEGING AN UNNAMED DEFICIENCY. THE EXPLANTING SURGEON IS NOT AFFILIATED WITH PLUS ORTHOPEDICS AND CANNOT BE REACHED FOR COMMENT. ATTORNEYS FOR PLUS HAVE RELAYED THAT THE SURGEON TOLD THE PT THAT THE DEVICE FAILED BECAUSE OF "A CLASSIC CASE OF OVER-CURING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI --- PLUS ORTHOPEDICS AG NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other