BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 2210862 · Received August 12, 2011

    Report

    Report Number
    2024312-2011-00224
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR ALLEGED THAT THREE (3) CROWNS IN AS MANY PATIENTS DE-BONDED WITHIN TWO (2) TO THREE (3) WEEKS AFTER PLACEMENT USING MAXCEM ELITE. THE DOCTOR RE-CEMENTED TWO (2) CROWNS AND THE THIRD HAD TO BE REMADE. AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS BEEN RETURNED. AN EVALUATION WILL BE INITIATED UPON RECEIPT OF THE RETURNED PRODUCT. NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A RETAIN SAMPLE WAS EVALUATED FOR ADHESIVE STRENGTH AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE RESULTS OF THIS INVESTIGATION INDICATE THAT THIS WAS AN ISOLATED OCCURENCE AND NOT RELATED TO A FAILURE OF THE KERR PRODUCT MAXCEM ELITE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATED. THERE WAS NOT ENOUGH MATERIAL IN THE SYRINGE OF THE RETURNED SAMPLE TO PERFORM TESTS. THE GENERAL VISUAL INSPECTION FOUND THAT THE LABEL ON THE RETURNED PRODUCT IS INCONSISTENT WITH THE LABEL OF THE RETAIN SAMPLES WITH THE SAME LOT NUMBER. AFTER EVALUATION, IT WAS DETERMINED THAT THE ACTUAL PRODUCT INVOLVED IN THE INCIDENT WAS NOT MANUFACTURED BY KERR CORPORATION.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR ALLEGED THAT THREE (3) PATIENTS EXPERIENCED THE DEBONDING OF CROWNS AFTER PLACEMENT WITH MAXCEM ELITE. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM ELITE DENTAL CEMENT EMA KERR CORPORATION 3566373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R