BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITEK INC.

    MDR report key: 537234 · Received June 18, 2004

    Report

    Report Number
    MW1032331
    Event Type
    Death
    Date Received
    June 18, 2004
    Report Date
    June 8, 2004
    Manufacturer
    VITEK INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN 1983 PT REC'D THEIR FIRST SILASTIC TMJ IMPLANT. THE IMPLANT WAS REMOVED IN 1984 AND ANOTHER PUT IN AND LATER REMOVED IN 1986. THEY HAD PAIN THROUGHOUT THEIR BODY, ESPECIALLY THEIR ARMS, THEY BEGAN TO BE FORGETFUL, FATIGUE SET IN AND THEY WERE UNABLE TO TOLERATE THE SUN. JAW DYSFUNCTION/LOCKED UP. IN 1988 PT RECEIVED THE VITEK II TMJ IMPLANT. THIS IMPLANT CONTAINED PROPLAST AND THEIR JAW BONES CRUMBLED. IN 1997 THEY HAD THE DEVICE TAKEN OUT DUE TO WARNING LETTERS THEY RECEIVED FROM THE FDA. THE IMPLANT PERFORATED THE SKULL. IN 1997 PT REC'D A CHRSTENSEN TOTAL JOINT REPLACEMENT. AFTER THE IMPLANTS WERE PUT IN THEY COULDN'T CHEW FOOD. THEY WERE AT A PROPER WEIGHT, BUT AFTER RECEIVING THE IMPLANT THEY WENT DOWNHILL AND WEIGHED ONLY 65 LBS AT THE TIME OF THEIR DEATH. IN 2000/2001 THEY BEGAN EXPERIENCING STROKES AND SEIZURES AND BEGAN SPENDING MOST OF THE TIME IN BED. THE PAIN WORSENED AND THEY DEVELOPED OTHER MEDICAL PROBLEMS SUCH AS VISION PROBLEMS, FEVERS, A HOLE IN BLADDER, TROUBLE SWALLOWING, ACCELERATED PULSE RATE, AND EXTREME FATIGUE. IN 2/04 THEY SLIPPED INTO A COMA AND PASSED AWAY. THEY PASSED AWAY DUE TO: GASTROINTESTINAL BLEEDING, TOXIC EFFECTS OF TMJ/JAW IMPLANTS, TEMPOROMANDIBULAR JOINT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK INC. TMJ IMPLANT DEVICE LZD VITEK INC. * *
    2 TMJ IMPLANTS TOTAL JOINT JAW JOINT IMPLANT LZD TMJ IMPLANTS, INC. * *
    3 DOW CORNING SILASTIC TMJ IMPLANT TMJ IMPLANT LZD DOW CORNING * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| L| S