BEUDAMED
    FDA Adverse Event Summary report: N

    TMJ PROPLAST PROSTHESIS

    MDR report key: 11369 · Received February 1, 1994

    Report

    Report Number
    MW4000138
    Date Received
    February 1, 1994
    Report Date
    March 19, 1993
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 1/26/82, DUE TO TRAUMA RECEIVED ON HER FACE, DR PLACED A PROSTHESIS AT PT'S RIGHT TMJ. RPTR HAD SUBSEQUENT YRS OF EXCESSIVE SWELLING, REDNESS, PRESSURE PAIN IN THE RIGHT EAR, PRESSURE PAIN ON THE LEFT SIDE OF FACE AND THE LEFT TMJ, AND VISIBLE MALFORMATION IN FACE AND BITE. IN 1/93 RPTR CHANGED DRS DUE TO THE INADEQUACY OF DR'S CARE. IT WAS AT THAT TIME THAT SHE LEARNED OF THE FDA RECALL OF THIS PROSTHESIS IN 1986. ON 2/23/93, THIS PROSTHESIS WAS REMOVED. RPTR STILL HAS SEVERE PAIN, PERIODIC SWELLING, AND REDNESS, HOWEVER, THE DEGREE OF SEVERITY HAS LESSENED SOMEWHAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *