BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM

    MDR report key: 1171766 · Received September 24, 2008

    Report

    Report Number
    2024312-2008-00027
    Event Type
    Injury
    Date Received
    September 24, 2008
    Report Date
    August 26, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K041474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PFM 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 RETURNED DEVICE AND RETAIN SAMPLES WERE TESTED FOR ADHESIVE STRENGTH TEST AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THIS IS THE SECOND MDR REPORT OF THE FOUR INCIDENTS REPORTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON AUGUST 26, 2008, KERR CORPORATION RECEIVED A LETTER IN WHICH A DOCTOR ALLEGED THAT PFM CROWNS PLACED WITH MAXCEM ON FOUR DIFFERENT PATIENTS HAD FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM CEMENT, DENTAL EMA KERR CORPORATION 2747522

    Patients

    Seq Age Sex Outcome Treatment
    1 Other