BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE

    MDR report key: 3110166 · Received May 13, 2013

    Report

    Report Number
    2024312-2013-00242
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    March 7, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD EXPERIENCED A CROWN ON TOOTH #3 AND #4 WHICH THE DOCTOR FELT WAS NOT SEATED PROPERLY; HOWEVER, THE PATIENT HAS NOT RETURNED FOR ANY FURTHER TREATMENT. REGULATORY AFFAIRS WILL UPDATE THIS COMPLAINT IF ANY NEW INFORMATION IS RECEIVED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. LOT # 4710900 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND VERIFIED AS A RECALLED LOT OF MAXCEM ELITE. THE DEVICE PROBLEM IS ALREADY KNOWN; THEREFORE, NO EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT A PATIENT'S CROWN WAS NOT SEATED PROPERLY DUE TO THE MAXCEM ELITE CEMENT SETTING UP TOO QUICKLY. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209861 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4710900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention