BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITEK IMPLANTS

    MDR report key: 285647 · Received July 11, 2000

    Report

    Report Number
    MW1019281
    Event Type
    Other
    Date Received
    July 11, 2000
    Report Date
    July 11, 2000
    Manufacturer
    VITEK, INC
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER HAD VITEK JAW JOINT IMPLANTS IN THE FALL OF 1986. THE LEFT IMPLANT FAILED AFTER 4 MONTHS. THE RIGHT IMPLANT REMAINED IN REPORTER'S JOINT UNTIL 1988. THIS HAS CAUSED THE GIANT CELL FOREIGN BODY REACTION AS WELL AS 3 MORE SURGERIES AND RADIATION AND ANOTHER ROUND OF ORTHODONTICS, NOT TO MENTION THE EVER PRESENT PAIN AND ASYMMETRY OF REPORTER'S FACE. REPORTER'S DOCTOR SAYS "I NOW NEED A TOTAL TITANIUM JOINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK IMPLANTS JAW/FOSSA JOINT IMPLANTS LZD VITEK, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other