BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 4013080 · Received August 15, 2014

    Report

    Report Number
    2024312-2014-00583
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE OFFICE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE MAXCEM ELITE WHICH HAD BEEN USED ON THE PATIENT; THEREFORE, NO CATALOG NUMBER, LOT NUMBER, OR EXPIRATION DATE WAS IDENTIFIED IN THIS REPORT. THE BRIDGE WAS INITIALLY PLACED ON (B)(6) 2010. THE PATIENT RETURNED TO THE DOCTOR'S OFFICE ON (B)(6) 2014 WITH THE DEBONDED BRIDGE; THE DOCTOR CLEANED IT OUT AND RE-CEMENTED IT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT MULTIPLE PATIENTS HAD EXPERIENCED THE DEBONDING OF A CROWN AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR; HOWEVER, SPECIFIC INCIDENT INFORMATION COULD ONLY BE RECALLED FOR SEVEN (7) PATIENTS. THIS IS THE SIXTH OF EIGHT (8) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489177 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R