BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLAST

    MDR report key: 8111 · Received March 17, 1994

    Report

    Report Number
    8111
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    February 2, 1994
    Report Date
    March 17, 1994
    Manufacturer
    VITEK, INC.
    Product Code
    LZD
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TMJ IMPLANT REMOVED FROM LEFT TMJ AND SENT TO PATHOLOGY. PATHOLOGIST REPORTED CALCIFICATION FIBROSIS, DEGENERATION, AND MARKED FOREIGN BODY REACTION.INVALID 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION, UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. 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 PROPLAST Implant TMJ IMPLANT LZD VITEK, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other