BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT THUMB CONDYLAR IMPLANT

    MDR report key: 33156 · Received April 22, 1996

    Report

    Report Number
    33156
    Event Type
    Malfunction
    Date Received
    April 22, 1996
    Date of Event
    March 28, 1996
    Report Date
    April 22, 1996
    Manufacturer
    UNKNOWN
    Product Code
    KWG
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF CRACKED LEFT THUMB CONDYLAR IMPLANT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. 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 LEFT THUMB CONDYLAR IMPLANT Implant CONDYLAR IMPLANT KWG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other