BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLAST TEFLON MANDIBULAR IMPLANT

    MDR report key: 36365 · Received August 29, 1996

    Report

    Report Number
    MW1009839
    Event Type
    Injury
    Date Received
    August 29, 1996
    Date of Event
    August 15, 1996
    Report Date
    August 20, 1996
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A TEFLON IMPLANT INSERTED IN 1986. THE PROSTHESIS WAS INSERTED INTO THE RIGHT TEMPOROMANDIBULAR JOINT. PT DEVELOPED PAIN ON OPENING AND CLOSING OF JAW DURING LAST SEVERAL MONTHS. CT SCAN REVEALS CONSIDERABLE AREA OF DEGENERATION OF THE MANDIBULAR CONDYLE AND BONE REACTION OF THE TEMPORAL BONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention