BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK INC.

    MDR report key: 558345 · Received September 30, 2004

    Report

    Report Number
    MW1033564
    Event Type
    Injury
    Date Received
    September 30, 2004
    Report Date
    September 30, 2004
    Manufacturer
    VITEK INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED VITEK TMJ IMPLANTS. IMPLANT WAS REMOVED IN 1990. OCT. 2002 AND JULY 2003 DEVELOPED TUMORS, ONE ABOVE LEFT EYE AND THE OTHER BEHIND LEFT EAR. CURRENTLY HAS FIBROMYALGIA, HEADACHES, EAR ACHES, SLEEP APNEA. 1992 HAD HYSTERECTOMY WHICH GYNEOCOLOGIST SAID MAY BE LINKED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK INC. TMJ IMPLANT DEVICE LZD VITEK INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening