BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 DUAL CURE CLEAR

    MDR report key: 2180011 · Received July 27, 2011

    Report

    Report Number
    2024312-2011-00189
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    May 18, 2011
    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

    THE DOCTOR REPORTED THAT A PATIENT EXPERIENCED THE DEBONDING OF A VENEER THAT HAD INITIALLY BEEN PLACED WITH NX3 DUAL CURE CEMENT. THE PATIENT IS DOING FINE AND THE VENEER WAS RECEMENTED. THREE LOTS WERE IDENTIFIED BY THE DOCTORS OFFICE, HOWEVER THE LOTS WERE NOT SPECIFIED IN THIS PARTICULAR INCIDENT. THE PRODUCTS WERE NOT RETURNED FROM THE DOCTOR, THEREFORE RETAIN SAMPLES WERE TESTED FOR ALL THREE LOTS. AN ADHESIVE STRENGTH TEST USING SILANE PRIMER WAS DONE ON ALL THREE LOTS. THE RESULTS OF THE ADHESIVE STRENGTH TESTS WERE WITHIN PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS OF EACH OF THE PRODUCTS USED INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES IN THE MANUFACTURING PROCESS OF THESE PRODUCTS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED REGARDING THE PRODUCT LOTS IN QUESTION. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THIS INCIDENT IS AN ISOLATED INCIDENT AND THAT THE CAUSE FOR THE DEBONDS WAS DUE TO A USER OR TECHNIQUE-RELATED PROBLEM UNDISCLOSED BY THE DOCTOR, AND NOT DUE TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR ALLEGED THAT TWO PATIENTS EXPERIENCED MULTIPLE DEBONDING THAT HAD BEEN PLACED WITH NX3. THE FIRST OUT OF THE TWO PATIENTS HAD A VENEER FAILED TWICE AND THE CEMENT WAS FOUND TO BE BONDED TO THE TOOTH. THIS MDR IS THE FIRST OF TWO REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other