BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE

    MDR report key: 3111266 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00254
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 13, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER AND AGE WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR WAS ABLE TO FULLY SEAT THE CROWN, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. THE LOT NUMBER 4720555 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'S OFFICE ALLEGED THAT THE CEMENT WAS SETTING UP TOO QUICKLY DURING. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212028 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4720555

    Patients

    Seq Age Sex Outcome Treatment
    1