BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLAST TEFLON IMPLANT

    MDR report key: 11023 · Received January 21, 1994

    Report

    Report Number
    MW1000459
    Event Type
    Injury
    Date Received
    January 21, 1994
    Report Date
    January 17, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOREIGN BODY GIANT CELL REACTION, ANKLYOSIS, OSTEOARTHRITIS, AND BONE SPURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLAST TEFLON IMPLANT Implant TEFLON TMJ IMPLANT LZD VITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Not Applicable| H| O