BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3043525 · Received April 9, 2013

    Report

    Report Number
    2024312-2013-00118
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE LOSS OF THE RESTORATIONS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4690551 AND 4728088. UPON THE PATIENT'S RETURN VISIT ON (B)(6) 2013, THE PATIENT HAD THE ABUTMENT AND CROWNS FOR TEETH NUMBERS 13 AND 14 RE-DONE. THE DOCTOR REMOVED THE CROWNS AND PLACE TEMPORARY CROWNS FOR THE PATIENT. THE PATIENT IS SCHEDULED FOR FINAL CEMENTATION IN A APPROXIMATELY THREE (3) WEEKS. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED. THE LOT NUMBERS 4690551 AND 4728088 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE, NO FURTHER EVALUATIONS ARE NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS OF MAXCEM ELITE, WHICH WERE ALLEGED TO HAVE BEEN ASSOCIATED WITH THE CEMENT SETTING UP TOO QUICKLY FOR ONE PATIENT CAUSING THE DOCTOR RE-DO THE RESTORATION; HOWEVER, THE DOCTOR WAS NOT DEFINITIVE AS TO THE NUMBER OF PATIENTS AFFECTED WITH REGARD TO EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146356 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R