BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 CEMENT

    MDR report key: 3191118 · Received June 26, 2013

    Report

    Report Number
    2024312-2013-00304
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 19, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PATIENT IS DOING FINE; THE VENEER FOR THE LATERAL TOOTH WAS RE-CEMENTED USING THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THREE (3) PATIENTS EXPERIENCED THE DEBONDING OF VENEERS AFTER PLACEMENT WITH NX3 CEMENT AND OPTIBOND XTR. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291082 NX3 CEMENT DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R OPTIBOND XTR