BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK, INC.

    MDR report key: 1550700 · Received November 30, 2009

    Report

    Report Number
    MW5013767
    Event Type
    Injury
    Date Received
    November 30, 2009
    Report Date
    November 30, 2009
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED VITEK II -TMJ IMPLANT- IN 1990. DIDN'T RECEIVE NOTICE OF RECALL UNTIL APPROX 7 YEARS LATER. AT THIS TIME PT IS UNABLE TO FIND AN ORAL SURGEON TO REMOVE THE IMPLANT. WAS TOLD THERE IS A 98% CHANCE SHE'LL DIE DURING THE SURGERY, AND THERE IS NOTHING TO REPLACE IT WITH. PT HAS BEEN DIAGNOSED WITH CHRONIC FATIGUE AND IMMUNE DYSFUNCTION SYNDROME -NEUROLOGICAL ENCEPHALITIS- AND HAS BEEN UNABLE TO WORK SINCE 1991.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK, INC. VITEK II LZD VITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R