BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3111308 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00256
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS OF MAXCEM ELITE WHICH WERE ASSOCIATED WITH THE PRODUCT SETTING TOO QUICKLY, HE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4720564 AND 4720558. THE DOCTOR COULD NOT RECALL PATIENT OR INCIDENT DETAILS. TH ECOTOR TAPPED THE HOLES A SECOND TIME AND RE-CEMENTED THE POST USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE LOT NUMBERS 4720564 AND 4720558 HAVE BEEN IDENTIFIED AS AFFECTED LOTS WHICH ARE PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE WAS SETTING UP TOO QUICKLY WHILE SEATING A CROWN. THIS IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212785 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1