BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3767024 · Received April 23, 2014

    Report

    Report Number
    2024312-2014-00238
    Event Type
    Injury
    Date Received
    April 23, 2014
    Report Date
    February 19, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K013609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOT NUMBERS ASSOCIATED WITH THE DEBONDING OF CROWNS, HE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOT NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDE 4844571 AND 5007512. SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE PATIENT RETURNED TO THE OFFICE AND A NEW CROWN WAS CEMENTED USING A DIFFERENT PRODUCT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT FROM LOT #4844571 WAS RETURNED AND A PHYSICAL EVALUATION WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATION. THE PRODUCT FROM LOT #5007512 WAS NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO BOTH OF THE REPORTED LOTS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL WITH THE DOCTOR ON (B)(6) 2014, IT WAS ALLEGED THAT TWENTY-SIX (26) PATIENTS HAD EXPERIENCED THE LOSS OF A CROWN APPROXIMATELY THREE (3) WEEKS AFTER PLACEMENT WITH THE NX3 DUAL CURE CLEAR PRODUCT. THIS IS THE FIFTEENTH OF TWENTY-SIX (26) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245309 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R