BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEFLON PROPLAST INTERPOSITIONAL TMJ

    MDR report key: 11096 · Received January 28, 1994

    Report

    Report Number
    MW1000515
    Event Type
    Injury
    Date Received
    January 28, 1994
    Date of Event
    January 10, 1994
    Report Date
    January 11, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGICAL REMOVAL OF LEFT TM JOINT IMPLANT (INSERTED 5/88). DEVICE REMOVED DUE TO PAIN AND DECREASED RANGE OF MOTION. SURGICAL FINDINGS: R/O FOREIGN BODY GIANT CELL GRANULOMA AND EROSION OF ARTICULAR SURFACES OF BONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Not Applicable| H| R