BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3

    MDR report key: 3173744 · Received June 17, 2013

    Report

    Report Number
    2024312-2013-00288
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 31, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE DEBONDING OF RESTORATIONS, HE COULD NOT VERIFY WHICH LOTS WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN SECTION REPORT D-4 OF THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4711057, 4720876 AND 4679042. THE DOCTOR COULD NOT RECALL PATIENT OR INCIDENT DETAILS. THE DOCTOR RE-CEMENTED THE CROWN FOR THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED; THEREFORE, A RETAIN SAMPLE FOR LOT NUMBERS 4711057, 4720876 AND 4679042 WERE EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE MADE WITH REGARD TO THESE LOTS.

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER AND AGE WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR RE-CEMENTED THE RESTORATION USING A DIFFERENT PRODUCT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS USED IN THIS INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED. (B)(4): DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FOURTEEN (14) PATIENTS HAD EXPERIENCED THE DEBONDING OF RESTORATIONS AFTER PLACEMENT WITH THE NX3. THIS IS THE NINTH OF FOURTEEN (14) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273834 NX3 DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND XTR ADHESIVE