BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 2873060 · Received December 13, 2012

    Report

    Report Number
    8020994-2012-00006
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 27, 2012
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RE-CEMENTED THE PATIENT'S CROWN USING A TEMPORARY CEMENT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS RETURNED AND EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE LOSS OF THEIR ANTERIOR CROWNS APPROXIMATELY ONE (1) WEEK AFTER PLACEMENT WITH MAXCEM ELITE CLEAR. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 3821912

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R