BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3050840 · Received April 10, 2013

    Report

    Report Number
    2024312-2013-00097
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 28, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD EXPERIENCED A CROWN WHICH HAD NOT BEEN FULLY SEATED; THEREFORE, THE DOCTOR CUT THE CROWN OFF. THE PATIENT RETURNED TO THE OFFICE AT A LATER DATE AND A NEW CROWN WAS PLACED USING MAXCEM ELITE CLEAR, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAIN SAMPLE, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE CLEAR HAD SET UP TOO QUICKLY DURING PROCEDURES ON TWO (2) PATIENTS. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153522 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION 4501668

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R