BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE

    MDR report key: 3111015 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00243
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO DIFFERENT LOT ASSOCIATED WITH THE CEMENT SETTING TOO QUICKLY, HE COULD NOT VERIFY WHICH LOT WAS USE ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4663716 AND 4741721. THE DOCTOR COULD NOT RECALL PATIENT OR INCIDENT DETAILS. THE DOCTOR REMOVED THE CROWN BEFORE IT BONDED WITH THE TOOTH, CLEANED OUT THE CEMENT AND RE-CEMENTED THE RESTORATION WITH THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. LOTS 4663716 AND 4741721 HAD BEEN IDENTIFIED AS AFFECTED LOTS WHICH ARE PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE NO FURTHER EVALUATIONS ARE NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE MAXCEM ELITE WAS SETTING UP TOO QUICKLY FOR SIX (6) PATIENTS. THIS IS THE FIRST OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213239 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention