BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3043048 · Received April 9, 2013

    Report

    Report Number
    2024312-2013-00108
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR RE-CEMENTED THE CROWN USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED YIELDING WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, THERE WERE NO SIMILAR COMPLAINTS WITH REGARDS TO THIS LOT.

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR RE-CEMENTED THE CROWN USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A RETAIN SAMPLE WAS EVALUATED YIELDING WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, THERE WERE NO SIMILAR COMPLAINTS WITH REGARDS TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY EIGHT (8) PATIENTS HAD EXPERIENCED THE LOSS OF A CROWN AFTER PLACEMENT WITH MAXCEM ELITE PRODUCT. THIS IS THE FOURTH OF EIGHT (8) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145300 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4673780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R