BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3050713 · Received April 10, 2013

    Report

    Report Number
    2024312-2013-00119
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 13, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RE-CEMENTED A NEW CROWN FOR THE PATIENT USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS GIVEN XANAX TO RELAX HIM. UPON THE PATIENTS RETURN ON (B)(6) 2013, THE DOCTOR TOOK AN X-RAY AND REPORTED THAT THERE WAS STILL CEMENT UNDER THE GUM TISSUE. DURING THE LAST WEEK OF MARCH, THE PATIENT RETURNED TO HAVE THE CROWN CUT OFF, RE-PREPPED, AND HAS A TEMPORARY PLACED. THE PATIENT WAS GIVEN XANAX TO RELAX HIM DURING THE PROCEDURE. THE PATIENT IS SCHEDULED TO RETURN FOR FINAL CEMENTATION IN TWO (2) WEEKS. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT IN INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. THE LOT NUMBER 4720558, HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE CEMENT WAS SETTING UP TOO QUICKLY FOR ONE PATIENT LEAVING CEMENT UNDER THE GUM TISSUE AND CAUSING THE CROWN NOT TO BE SEATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152698 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4720558

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R