BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 1221745 · Received November 7, 2008

    Report

    Report Number
    2024312-2008-00034
    Event Type
    Injury
    Date Received
    November 7, 2008
    Report Date
    October 9, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS' CROWNS 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 OF THE CLEAR SHADE ALLEGED TO HAVE BEEN INVOLVED IN THESE INCIDENTS WAS TESTED FOR ADHESIVE STRENGTH. THE RESULTS INDICATED THAT THE ADHESION DATA WAS ACCEPTABLE. THIS IS THE SECOND MDR REPORT OF THE TWO INCIDENTS REPORTED.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED THAT CROWNS 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 3000369

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other