BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 DUAL CURE

    MDR report key: 3902713 · Received June 30, 2014

    Report

    Report Number
    2024312-2014-00479
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 18, 2014
    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

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE DOCTOR'S OFFICE COULD NOT RECALL SPECIFIC PATIENT INFORMATION. THE PATIENT HAD EXPERIENCED THE DEBONDING OF RESTORATION APPROXIMATELY SEVERAL MONTHS AFTER PLACEMENT. THE DOCTOR EITHER CLEANED AND RE-CEMENTED THE CROWN OR HAD A NEW CROWN MADE AND CEMENTED IT FOR THE PATIENT USING THE SAME PRODUCTS WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT APPROXIMATELY FIVE (5) PATIENTS HAD EXPERIENCED THE DEBONDING OF A RESTORATION AFTER PLACEMENT WITH NX3 AND OPTIBOND ALL IN ONE PRODUCTS. THIS IS THE THIRD OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379476 NX3 DUAL CURE DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND ALL IN ONE