BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3110116 · Received May 13, 2013

    Report

    Report Number
    2024312-2013-00238
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    February 25, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. TO DATE, THE PATIENT IS DOING FINE. THE DOCTOR REMOVED THE CROWN, CLEANED IT AND RE-CEMENTED THE RESTORATION WITH THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. THE LOT NUMBER 4704821 ALLEGED IN THIS REPORT HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE, NO FURTHER EVALUATIONS ARE NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE WAS SETTING UP TOO QUICKLY. THIS IS THE SEVENTH OF TEN (10) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210722 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4704821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R