BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3850863 · Received June 5, 2014

    Report

    Report Number
    2024312-2014-00455
    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. THE DOCTOR EITHER CEMENTED A NEW CROWN OR RE-CEMENTED THE EXISTING DEBONDED CROWN FOR THE PATIENT USING EITHER THE SAME PRODUCTS OR DIFFERENT 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 SECOND OF THIRTEEN (13) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330187 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND XTR