BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NX3

    MDR report key: 1182123 · Received October 2, 2008

    Report

    Report Number
    2024312-2008-00030
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Report Date
    September 3, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS' VENEERS WERE RECEMENTED USING A DIFFERENT PRODUCT WITHOUT INCIDENT. THE PATIENTS ARE DOING FINE. THE DEVICE WAS NOT RETURNED TO KERR CORPORATION FOR EVALUATION. THE RETAIN SAMPLES UNDERWENT ADHESIVE STRENGTH TESTING. THE RESULTS INDICATED THAT THE PRODUCT WAS WITHIN SPECIFICATIONS. THIS IS THE FIRST MDR REPORT OF THE TWO INCIDENTS REPORTED.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT WAS RETURNED TO KERR CORPORATION FOR EVALUATION. THE RETURNED DEVICE WAS EMPTY AND AN EVALUATION COULD NOT BE PERFORMED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED THAT VENEERS PLACED WITH NX3 ON TWO DIFFERENT PATIENTS HAD FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NX3 DENTAL CEMENT EMA KERR CORPORATION 2976662

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other