BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 2073426 · Received May 1, 2011

    Report

    Report Number
    2024312-2011-00105
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CROWN WAS RECEMENTED USING A DIFFERENT LOT OF MAXCEM ELITE WITHOUT FURTHER INCIDENT. THE PATIENT IS DOING FINE. THE RETURNED PRODUCT WAS EVALUATED FOR ADHESIVE STRENGTH AND MET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE PRODUCTION PROCESS. IN ADDITION, A REVIEW OF COMPLAINT DATABASE TRENDING SHOWED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS LOT WHICH INDICATES THAT THIS IS AN ISOLATED INCIDENT. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THE DEBONDS MAY HAVE BEEN DUE TO A USER OR TECHNIQUE-RELATED PROBLEM AND WERE NOT THE RESULT OF A PRODUCT FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A DOCTOR ALLEGED THAT FOUR (4) PATIENTS EXPERIENCED THE DEBONDING OF CROWNS THAT HAD BEEN PLACED WITH MAXCEM ELITE. THIS MDR IS THE THIRD OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM ELITE DENTAL CEMENT EMA KERR CORPORATION 3566373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R