BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE

    MDR report key: 3111073 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00229
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR CLEANED THE CROWN AND RE-CEMENTED THE RESTORATION WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE LOTS 4702597 AND 4772055 HAS BEEN IDENTIFIED AS AFFECTED LOTS WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, THERE WERE NO SIMILAR COMPLAINTS IN REGARDS TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE WAS SETTING UP TOO QUICKLY. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211934 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention