BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPLEX C IMPLANT

    MDR report key: 554728 · Received November 12, 2004

    Report

    Report Number
    2029012-2004-00067
    Event Type
    Other
    Date Received
    November 12, 2004
    Date of Event
    September 14, 2004
    Report Date
    November 12, 2004
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    JDK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A SCHEDULED REVISION SURGERY, A BIOPLEX IMPLANT WAS DISCOVERED TO BE FRACTURED IN SEVERAL PLACES. THE PIECES WERE SUBSEQUENTLY DISCARDED IN THE OPERATING ROOM. THE IMPLANT WAS REPLACED WITH A NEW ONE. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLEX C IMPLANT CEMENT RESTRICTOR JDK INTERPORE CROSS INTL. NA 410501

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R