BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3884298 · Received June 19, 2014

    Report

    Report Number
    2024312-2014-00471
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE, AND WEIGHT WAS NOT PROVIDED. SPECIFIC PRODUCT INFORMATION WITH REGARD TO CATALOG NUMBER, LOT NUMBER, OR EXPIRATION DATE WAS NOT PROVIDED. THE PATIENT RETURNED TO THE OFFICE ON (B)(6) 2014, AND THE DOCTOR NOTED THAT THE PATIENT'S TOOTH WAS FRACTURED. THE DOCTOR PLACED A TEMPORARY RESTORATION ON THE TOOTH. THE DOCTOR REPORTED THAT THE PATIENT IS CURRENTLY UNDERGOING FURTHER TREATMENT AND MAY REQUIRE A TOOTH EXTRACTION; HOWEVER, THE EXTRACTION IS DUE TO THE TOOTH FRACTURE WHICH THE DOCTOR CONFIRMED WAS UNRELATED TO THE USE OF THE NX3 PRODUCT AND/OR DEBONDING OF THE CROWN. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE NX3 CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360077 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R SINGLEBOND| Z-PRIME PLUS