BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM

    MDR report key: 1071444 · Received July 10, 2008

    Report

    Report Number
    2024312-2008-00007
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 11, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K041474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S CROWN WAS RECEMENTED WITH A DIFFERENT PRODUCT WITHOUT INCIDENT. THE PATIENT IS DOING FINE. THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED TO KERR CORPORATION FOR EVALUATION. THE DEVICE AND RETAIN SAMPLES WERE TESTED FOR ADHESIVE STRENGTH TESTS AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THIS IS THE SECOND MDR REPORT OF THE TWO INCIDENTS REPORTED. - ATTACHMENT: [MAXCEM 2024312-2008-00007 - EVALUATION.PDF]

    Description of Event or Problem · 1

    IN 2008, A DOCTOR ALLEGED THAT CROWNS PLACED WITH MAXCEM ON TWO DIFFERENT PATIENTS HAD FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM DENTAL CEMENT EMA KERR CORPORATION 2760277

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other