BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPOSITIONAL TMJ TEFLON PROPLAST IMPLANT

    MDR report key: 11194 · Received February 2, 1994

    Report

    Report Number
    MW1000565
    Event Type
    Injury
    Date Received
    February 2, 1994
    Date of Event
    August 23, 1989
    Report Date
    January 12, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILATERAL IMPLANTS WERE PLACED IN THE PT'S TM JOINTS AT ANOTHER SURGEON'S OFFICE. ONE AND 1/2 YRS LATER SHE PRESENT TO RPTR WITH CLASSIC SYMPTOMS: PAIN, RESTRICTION OF MOTION AND BITE CHANGES. THE IMPLANTS WERE REMOVED, ALONG WITH A GIANT CELL GRANULOMA, BILATERALLY. SHE HAS SINCE HAD SKIN GRAFTS (DERMAL) AND ARTHROSCOPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Not Applicable| H| R