BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3041576 · Received April 8, 2013

    Report

    Report Number
    2024312-2013-00104
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 11, 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
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIES THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE CEMENT SETTING UP TOO QUICKLY, HE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBER 4720580, 4651044, AND 4720568. PATIENT SPECIFICS WITH REGARD TO GENDER AND AGE WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR ADJUSTED THE OCCLUSION OF THE CROWN TO MAKE IT FIT. UPON THE PATIENT RETURN VISIT, THE DOCTOR CUT OFF THE CROWN AND RE-CEMENTED THE CROWN, WITHOUT FURTHER INCIDENT. TO DATE THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED. THE LOTS NUMBER 4720580 AND 4720568 HAS BEEN IDENTIFIED AS AFFECTED LOTS WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL. A RETAIN SAMPLE OF LOT 4651044 WAS EVALUATED YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FORM THE MANUFACTURING PROCESS. IN ADDITION, THERE WERE NO SIMILIAR COMPLAINTS IN REGARDS TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY TWO (2) PATIENTS HAD EXPERIENCED THE MAXCEM ELITE PRODUCT SETTING UP TOO QUICKLY LEAVING OPEN MARGINS. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143141 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R