BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROPLAST TEFLON TMJ FOSSA IMPLANT

    MDR report key: 10914 · Received January 10, 1994

    Report

    Report Number
    MW1000359
    Event Type
    Other
    Date Received
    January 10, 1994
    Report Date
    December 23, 1993
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD PRE-AURICULAR AND TEMPORAL PAIN ON LEFT SIDE. STATUS 7 YRS POST-OP: LEFT MANDIBULAR CONDYLECTOMY WITH INSERTION OF IMPLANT AND FREEZE DRIED DURA IMPLANT (12/26/86). STATUS 3 YRS 7 MOS POST-OP: EXCISION "CALCIFIED MASS" LEFT TMJ. FOSSA IMPLANT STILL IN PLACE. PT COMPLAINING OF 4 MOS HISTORY OF INCREASED LEFT TMJ AND TEMPORAL PAIN, AND INCREASING LIMITATION OF OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLAST TEFLON TMJ FOSSA IMPLANT Implant LZD VITEK, INC. 913.09 (VK LEFT 9 MM)

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other