BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ IMPLANT

    MDR report key: 8112 · Received March 23, 1994

    Report

    Report Number
    8112
    Event Type
    Injury
    Date Received
    March 23, 1994
    Date of Event
    February 23, 1994
    Report Date
    March 23, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RIGHT TMJ IMPLANTED IN 1985. PT COMPLAINED OF PAIN AND LIMITED MOVEMENT OF LOWER JAW. EXPLANTED ON 2/23/94. PATHOLOGY REVEALED FOREIGN BODY REACTION AND DEGENERATION.DEVICE LABELED FOR SINGLE USE. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ IMPLANT Implant TMJ IMPLANT LZD VITEK, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other