BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3083658 · Received April 29, 2013

    Report

    Report Number
    2024312-2013-00143
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 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

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE DOCTOR OBSERVED THAT THE CROWN WAS NOT SEATED PROPERLY, IMMEDIATELY REMOVED IT, AND THEN CLEANED THE CEMENT FROM THE TOOTH; HOWEVER, THE CEMENT WHICH HAD SET UP INSIDE OF THE CROWN COULD NOT BE REMOVED. A NEW CROWN WAS MADE AND THE PATIENT RETURNED TO THE DENTAL OFFICE ON (B)(6) 2013 FOR FINAL CEMENTATION. THE NEW CROWN WAS CEMENTED USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. LOT NUMBER 4690551 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE CEMENT HAD SET UP TOO QUICKLY WHILE SEATING A PATIENT'S CROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183653 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION 4690551

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R