BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 LIGHT CURE CEMENT

    MDR report key: 3150128 · Received June 6, 2013

    Report

    Report Number
    2024312-2013-00266
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 7, 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 VENEERS FOR TOOTH NUMBERS SEVEN (7) AND EIGHT (8) WERE RE-CEMENTED USING THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. THE RETURNED PRODUCTS AND RETAIN SAMPLES WERE EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW OF ALL OF THE LOTS REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THESE LOTS. THESE INVESTIGATION RESULTS SUGGEST THAT THIS IS AN ISOLATED INCIDENT THAT OCCURRED AS A RESULT OF A USER/TECHNIQUE RELATED ISSUE AND WAS NOT DUE TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED THE DEBONDING OF VENEERS AFTER PLACEMENT WITH NX3 LIGHT CURE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250781 NX3 LIGHT CURE CEMENT DENTAL CEMENT EMA KERR CORPORATION 4657759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R