BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3072555 · Received April 23, 2013

    Report

    Report Number
    2024312-2013-00133
    Event Type
    Injury
    Date Received
    April 23, 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

    AN X-RAY WAS TAKEN FOR THE PATIENT AND THE DOCTOR NOTICED THAT THE CROWN WAS NOT FULLY SEATED. THE DOCTOR HAD RE-CEMENTED THE RESTORATION FOR THE PATIENT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE CEMENT WAS SETTING UP TOO QUICKLY FOR TWO (2) PATIENTS CAUSING THEIR CROWNS TO NOT BE FULLY SEATED. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175487 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R