BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM

    MDR report key: 1070883 · Received July 9, 2008

    Report

    Report Number
    2024312-2008-00004
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K041474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DEVICE WAS RETURNED TO KERR CORPORATION, HOWEVER THE DEVICE WAS EMPTY AND DID NOT CONTAIN ENOUGH MATERIAL FOR EVALUATION. THE RETAIN SAMPLE WAS TESTED FOR ADHESIVE STRENGTH TEST AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THIS IS THE FIRST MDR REPORT OF THE TWO INCIDENTS REPORTED.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR ALLEGED THAT PFM 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 2860067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other