BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3250995 · Received July 29, 2013

    Report

    Report Number
    2024312-2013-00395
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    March 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE DOCTOR HAD SEATED A POST WITH CROWN ATTACHED ON TOOTH #21 FOR THE PATIENT; HOWEVER, THE CEMENT HAD SET TOO QUICKLY AND THE CROWN WAS SEATED TOO HIGH. THE DOCTOR REMOVED THE RESTORATION, CLEANED IT OUT AND RE-SEATED IT; HOWEVER, THE DOCTOR BELIEVED HE MAY HAVE PERFORATED THE CANAL OF THE TOOTH WHILE REMOVING THE CEMENT. ON (B)(6) 2013, THE PATIENT REPORTED EXPERIENCING PAIN AND SWELLING IN THE TOOTH. AN X-RAY WAS TAKEN AND CONFIRMED THE CANAL WAS PERFORATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (AMOXICILLIN) FOR TREATMENT. ON (B)(6) 2013, THE PATIENT REPORTED STILL EXPERIENCING PAIN AND SWELLING; THEREFORE, THE DOCTOR EXTRACTED THE TOOTH. ON (B)(6) 2013, A NEW RESTORATION WAS CEMENTED USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE DOCTOR ALLEGED THAT THE MAXCEM ELITE RELATED TO THIS ALLEGED SERIOUS INJURY WAS PART OF AN ONGOING RECALL, BUT COULD NOT CONFIRM THE EXACT LOT NUMBER OF THE PRODUCT USED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE CLEAR HAD SET UP TOO QUICKLY WHILE SEATING RESTORATIONS FOR TWO (2) PATIENTS. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354083 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R