BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3111123 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00251
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE LOSS OF THE RESTORATIONS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4720558, 4704804 AND 4772304. THE DOCTOR REMOVED THE CROWN, CLEANED OUT THE CEMENT, AND RE-CEMENTED THE RESTORATION WITH THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS RETURNED. THE LOT NUMBERS 4720558, 4772304 AND 4772304 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 IDENTIFIED THREE (3) DIFFERENT LOTS OF MAXCEM ELITE, WHICH WERE ALLEGED TO HAVE SET TOO QUICKLY; HOWEVER, THE DOCTOR WAS NOT DEFINITIVE AS TO THE NUMBER OF PATIENTS AFFECTED WITH REGARD TO EACH LOT. THIS IS THE SIXTH OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212973 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R