BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3010836 · Received March 19, 2013

    Report

    Report Number
    2024312-2013-00082
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 21, 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 AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. TO DATE, THE PATIENT IS DOING FINE. THE CROWN WAS RE-CEMENTED WITH A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. THE PRODUCT WAS RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE; THEREFORE, A VISUAL TEST AND GEL SET TIME TEST WERE PERFORMED ON THE RETAINED PRODUCT. IT WAS CONFIRMED THAT THE PRODUCT DID NOT MEET POLYMERIZATION SPECIFICATIONS. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDES LOT NUMBERS 4427295 AND 4659429 HAS BEEN IDENTIFIED AS AFFECTED LOTS THAT IS PART OF AN ONGOING MAXCEM ELITE RECALL. THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USE ON EACH PATIENT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE CLEAR WAS SETTING UP TOO QUICKLY DURING PROCEDURES FOR TWO (2) PATIENTS; HOWEVER, PATIENT INCIDENT DETAILS WERE NOT PROVIDED. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114753 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R