BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 1951260 · Received January 6, 2011

    Report

    Report Number
    2024312-2011-00002
    Event Type
    Injury
    Date Received
    January 6, 2011
    Report Date
    December 8, 2010
    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 REPORTED THAT CROWNS THAT HAD BEEN PLACED WITH MAXCEM ELITE DEBONDED WITHIN ONE MONTH AFTER PLACEMENT. THE DOCTOR DID NOT SPECIFY THE NUMBER OF PATIENTS AFFECTED; HOWEVER THE DOCTOR DID IDENTIFY THREE LOTS OF MAXCEM ELITE THAT WERE IN USE AT THE TIME THE INCIDENTS OCCURRED. THE PRODUCT LOT INDICATED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION; THEREFORE A RETAIN SAMPLE WAS TESTED FOR ADHESIVE STRENGTH AND WAS FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE MANUFACTURING PROCESS OF THIS PRODUCT LOT. IN ADDITION, A REVIEW OF THE COMPLAINT DATABASE INDICATED THAT NO SIMILAR COMPLAINTS WERE RECEIVED REGARDING THIS PRODUCT LOT. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THIS INCIDENT IS AN ISOLATED INCIDENT AND THE CAUSE OF THE DEBONDS WAS DUE TO A USER OR TECHNIQUE-RELATED PROBLEM AND NOT DUE TO A PRODUCT FAILURE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED THAT CROWNS THAT HAD BEEN CEMENTED WITH MAXCEM ELITE DE-BONDED WITHIN ONE MONTH AFTER PLACEMENT. THIS IS THE SECOND OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXCEM ELITE DENTAL CEMENT EMA KERR CORPORATION 3544479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R