BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3680019 · Received March 14, 2014

    Report

    Report Number
    2024312-2014-00162
    Event Type
    Injury
    Date Received
    March 14, 2014
    Report Date
    February 12, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K013609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED FOUR (4) DIFFERENT LOTS ASSOCIATED WITH THE DEBONDING, SHE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4813434, 4855372, 4872984 AND 4950258. UPON THE PATIENT'S RETURN VISITS, THE DOCTOR CLEANED TOOTH #30 AND TOOK AN IMPRESSION, HOWEVER, THE CROWN FOR TOOTH #31 HAD DEBONDED WHEN THE IMPRESSION WAS PULLED. THE DOCTOR RE-CEMENTED THE CROWN FOR TOOTH #30 AND WILL RE-MAKE CROWN FOR TOOTH #31. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, AN 'ADHESIVE STRENGTH' TEST OF THE RETAIN SAMPLES WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE DEBONDING OF RESTORATIONS AFTER PLACEMENT USING THE NX3 CEMENT AND THE OPTIBOND XTR PRODUCTS. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153074 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND XTR