BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 DUAL CURE CLEAR

    MDR report key: 2022809 · Received March 17, 2011

    Report

    Report Number
    2024312-2011-00056
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE SEVEN ATTEMPTS TO CONTACT THE DOCTOR IN ORDER TO OBTAIN FURTHER DETAILS ON THIS INCIDENT, NO RESPONSE WAS RECEIVED. THE DOCTOR RETURNED THREE LOTS OF NX3, BUT DID NOT SPECIFY WHICH LOT WAS USED ON THE PATIENT. THE THREE LOTS WERE EVALUATED FOR ADHESIVE STRENGTH AND MET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR EACH LOT INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE PRODUCTION PROCESS. IN ADDITION, A REVIEW OF COMPLAINT DATABASE TRENDING FOR EACH LOT INDICATED THAT NO SIMILAR COMPLAINTS WERE RECEIVED. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THE DEBONDS WERE NOT THE RESULT OF A PRODUCT FAILURE AND MAY HAVE BEEN DUE TO A USER OR TECHNIQUE-RELATED PROBLEM. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR REPORTED THAT FIVE PATIENTS EXPERIENCED THE DEBONDING OF RESTORATIONS THAT HAD BEEN PLACED WITH NX3. THIS MDR IS THE FOURTH OF FIVE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other