BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK INC.

    MDR report key: 1550698 · Received November 30, 2009

    Report

    Report Number
    MW5013766
    Event Type
    Injury
    Date Received
    November 30, 2009
    Report Date
    November 30, 2009
    Manufacturer
    VITEK, INC.
    Product Code
    JAZ
    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 TMJ VITEK IMPLANT. PT NOW SUFFERS FROM MS-LIKE SYMPTOMS, TEFLON MATERIAL IN VITEK HAS EATEN THROUGH THE SKULL. VITEK IMPLANT REMOVED IN 1984. RECENTLY HAD A TUMOR REMOVED BEHIND EYE. TUMOR CONTAINED PIECES OF TEFLON. PT SUFFERS FROM A SEIZURE DISORDER AS A RESULT OF THE TMJ IMPLANT.

    Devices

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

    Patients

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