BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE

    MDR report key: 3110013 · Received May 13, 2013

    Report

    Report Number
    2024312-2013-00231
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    February 27, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR HAD TO MAKE ADJUSTMENTS ON THE CROWN AND BITE FOR THE PATIENT WITHOUT FURTHER INCIDENT. TO DATE THE PATIENT IS DOING FINE. THE PRODUCT HAS NOT BEEN RETURNED. THE LOT NUMBER 4690551 ALLEGED IN THIS REPORT HAS BEEN IDENTIFIED AS AN AFFECTED LOT THAT IS PART OF AN ONGOING MAXCEM ELITE RECALL.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE CLEAR PRODUCT HAD SET UP TOO QUICKLY WHILE CEMENTING A CROWN FOR SIX (6) PATIENTS. THIS IS THE THIRD OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210399 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4690551

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention