BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK PROPLAST TMJ IMPLANT

    MDR report key: 617 · Received May 21, 1992

    Report

    Report Number
    617
    Event Type
    Injury
    Date Received
    May 21, 1992
    Report Date
    May 4, 1992
    Manufacturer
    VITEK, INC
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    VITEK PROPLAST TMJ IMPLANTED AT ANOTHER FACILITY IN 1987. PRODUCT HAS BEEN RECALLED BY FDA. PATIENT COMPLAINED OF RIGHT TEMPOROMANDIBULAR JOINT PAIN FOR A YEAR. CLINICAL AND RADIOGRAPHIC EXAMINATIONS CONSISTENT WITH DIAGNOSIS OF INCREASED PROGRESSIVE DENGERATIVE JOINT DISEASE WITH BONY EROSION. CONSEQUENTLY, PHYSICIAN RECOMMENDED IMPLANT BE REMOVED. IT IS OUR UNDERSTANDING THAT VITEK, INC. IS IN BANKRUPTCY AND NO LONGER IN OPERATION SO THIS REPORT IS BEING SENT DIRECTLY TO THE FDAINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK PROPLAST TMJ IMPLANT Implant NONE LZD VITEK, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other