BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NX3

    MDR report key: 1000776 · Received February 21, 2008

    Report

    Report Number
    2024312-2008-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 7, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS SEEN BY A DIFFERENT DENTIST WHO RECEMENTED THE PT'S VENEERS USING A DIFFERENT PRODUCT WITHOUT INCIDENT. THE RETAIN SAMPLE WAS TESTED FOR ADHESIVE STRENGTH TEST AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR ALLEGED THAT TWO VENEERS PLACED USING NX3 HAD FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NX3 CEMENT, DENTAL EMA KERR CORPORATION 2742127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention