BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NX3 DUAL CURE

    MDR report key: 3953066 · Received July 23, 2014

    Report

    Report Number
    2024312-2014-00528
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    March 17, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K062519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDERS, AGES, AND WEIGHTS WERE NOT PROVIDED. THE OFFICE DID NOT PROVIDE AN EXACT NUMBER OF PATIENTS AFFECTED. THE OFFICE DID NOT PROVIDE A LOT NUMBER OR CATALOG NUMBER FOR THE PRODUCT USED; THEREFORE, NO INFORMATION COULD BE PROVIDED. ON (B)(6) 2014, KERR WAS NOTIFIED THAT THE OFFICE OF (B)(6) HAD EXPERIENCED ISSUES WITH THE NX3 DUAL CURE PRODUCT. NO FURTHER INFORMATION WAS SUPPLIED AT THAT TIME. MULTIPLE ATTEMPTS WERE MADE TO GATHER FURTHER INFORMATION; HOWEVER, THE COMPLAINANT DID NOT RESPOND. ON (B)(6) 2014, KERR WAS NOTIFIED THAT THE OFFICE HAD REPORTED THAT MULTIPLE PATIENTS HAD EXPERIENCED THE DISCOLORATION OF A RESTORATION. NO FURTHER INFORMATION WAS SUPPLIED AT THAT TIME. MULTIPLE ATTEMPTS WERE MADE TO GATHER FURTHER INFORMATION; HOWEVER, THE COMPLAINANT DID NOT RESPOND. ON (B)(6) 2014, IT WAS DISCOVERED BY A KERR REPRESENTATIVE THAT THE DOCTOR HAD REPEATED THE RESTORATION PROCEDURES FOR EACH OF THE PATIENTS. NO FURTHER INFORMATION WAS PROVIDED BY THE OFFICE. MULTIPLE ATTEMPTS WERE MADE BY KERR CORPORATION TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN FURTHER PATIENT AND INCIDENT INFORMATION; HOWEVER, THE COMPLAINANT HAS PROVIDED ONLY LIMITED INFORMATION AND HAS REMAINED UNRESPONSIVE TO FURTHER REQUESTS FOR INFORMATION. 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 MULTIPLE PATIENTS HAD EXPERIENCED THE DISCOLORATION OF A RESTORATION AFTER CEMENTATION WITH THE NX3 DUAL CURE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430893 NX3 DUAL CURE DENTAL CEMENT EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND SOLO PLUS