BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3111065 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00228
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR MODIFIED HIS PROCEDURE AND PLACED THE POST USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL TEST AND GEL SET TIME TEST WERE PERFORMED ON THE RETAINED PRODUCT. IT WAS CONFIRMED THAT THE PRODUCT DID NOT MEET POLYMERIZATION SPECIFICATIONS. THIS LOT # 4720553 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH 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 PATIENT'S CROWN ON TOOTH #20. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213372 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION 4720553

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention