BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3011695 · Received March 19, 2013

    Report

    Report Number
    2024312-2013-00070
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE LOSS OF THE RESTORATIONS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4548392 AND 4488161. THE PATIENT HAD EXPERIENCED THE LOSS OF THE SAME CROWN ON FOUR (4) SEPARATE OCCASIONS. THE FIRST LOSS OCCURRED ON (B)(6) 2012, ONE (1) DAY AFTER THE INITIAL PLACEMENT, AND THE SECOND LOSS OCCURRED ON (B)(6) 2012; HOWEVER, THE ASSISTANT WAS NOT DEFINITIVE AS TO WHETHER MAXCEM ELITE PRODUCT HAD BEEN USED TO RE-CEMENT THE RESTORATION FOLLOWING THESE INCIDENTS. THE THIRD LOSS OCCURRED ON (B)(6) 2012; THE DOCTOR CLEANED OUT THE RESTORATION HAD USED MAXCEM ELITE TO RE-CEMENT IT. THE FOURTH LOSS OCCURRED ON (B)(6) 2012; THE DOCTOR CLEANED OUT THE RESTORATION AND RE-CEMENTED IT USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT FROM LOT NUMBER 4548392, WAS NOT RETURNED; THEREFORE, A PHYSICAL TEST WAS PERFORMED ON RETAINED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. THE PRODUCT FROM LOT NUMBER 4488161, WAS RETURNED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE; THEREFORE, A PHYSICAL TEST WAS PERFORMED ON RETAINED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO EITHER LOT.

    Description of Event or Problem · 1

    A DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS OF MAXCEM ELITE, WHICH WERE ALLEGED TO HAVE BEEN ASSOCIATED WITH THE LOSS OF RESTORATIONS IN FIVE (5) PATIENTS; HOWEVER, THE DOCTOR WAS NOT DEFINITIVE AS TO THE NUMBER OF PATIENTS AFFECTED WITH REGARD TO EACH LOT. THIS IS THE SECOND OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114913 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R