BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 CLEAR

    MDR report key: 3173783 · Received June 17, 2013

    Report

    Report Number
    2024312-2013-00269
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K013609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING THE FIRST LOSS OF THE RESTORATION WAS NOT PROVIDED; HOWEVER, THE RESTORATION WAS RE-CEMENTED ON (B)(6) 2013 AND HAD DEBONDED A SECOND TIME ON (B)(6) 2013 WHILE THE PATIENT WAS EATING. TO DATE, THE PATIENT IS DOING FINE. A NEW RESTORATION WILL BE RE-CEMENTED ON (B)(6) 2013. THE PRODUCT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Additional Manufacturer Narrative · 1

    A NEW ONLAY WAS CEMENTED FOR THE PATIENT ON (B)(6) 2013 USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    A PATIENT HAD EXPERIENCED THE LOSS OF AN ONLAY ON TWO (2) SEPARATE OCCASIONS AFTER PLACEMENT WITH NX3 DUAL CURE CLEAR CEMENT AND OPTIBOND XTR ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273382 NX3 CLEAR DENTAL CEMENT EMA KERR CORPORATION 4780239

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R OPTIBOND XTR ADHESIVE