BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLAST

    MDR report key: 7380 · Received January 14, 1994

    Report

    Report Number
    7380
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    November 17, 1993
    Report Date
    December 28, 1993
    Manufacturer
    VITEK
    Product Code
    LJD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT HAD TEFLON TMJ IMPLANT PLACED IN LEFT TMJ 6/18/85. DURING PAST YEAR HAS EXPERIENCED PAIN, INTERMITTENT SWELLING, AND DEVIATION TO LEFT SIDE. IMPLANT REMOVED 11/17/93. PATHOLOGY REVIEW FOUND FOREIGN BODY GRANULOMA AND FIBROSIS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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: NONE OR UNKNOWN, OTHER, UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLAST Implant TEFLON PROPLAST LAMINATED FOSSA IMPLANT LJD VITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other