BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3851031 · Received June 5, 2014

    Report

    Report Number
    2024312-2014-00466
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. SPECIFIC PRODUCT INFORMATION WITH REGARD TO CATALOG NUMBER, LOT NUMBER, OR EXPIRATION DATE WAS NOT PROVIDED; THEREFORE, NO INFORMATION WAS PROVIDED IN THIS REPORT. THE PATIENT HAD EXPERIENCED THE DEBONDING OF A CROWN FROM TOOTH #18 AND RETURNED TO THE OFFICE ON (B)(6) 2014. THE DOCTOR CLEANED AND RE-CEMENTED THE RESTORATION USING THE SAME PRODUCTS. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THIRTEEN (13) PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN APPROXIMATELY THREE (3) TO SIX (6) MONTHS AFTER PLACEMENT WITH THE NX3 CEMENT AND OPTIBOND XTR PRODUCTS. OF THESE THIRTEEN (13) PATIENTS, SEVERAL HAD EXPERIENCED THE DEBONDING OF A CROWN A SECOND TIME; HOWEVER, NO SPECIFIC PATIENT OR INCIDENT INFORMATION WAS PROVIDED. THIS IS THE THIRTEENTH OF THIRTEEN (13) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329621 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND XTR