BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 1960511 · Received January 13, 2011

    Report

    Report Number
    2024312-2011-00007
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 13, 2010
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR REPORTED THAT A PATIENT LOST A CROWN THAT HAD BEEN PLACED WITH MAXCEM ELITE. THE CROWN WAS RECEMENTED WITH A DIFFERENT CEMENT AND THE PATIENT IS DOING FINE. THE DOCTOR IDENTIFIED TWO DIFFERENT LOTS OF MAXCEM ELITE, HOWEVER HE DID NOT SPECIFY WHICH LOT WAS USED IN THIS INCIDENT. BOTH LOTS WERE RETURNED FOR EVALUATION, BUT THE SYRINGE OF ONE LOT WAS RETURNED EMPTY; THEREFORE RETAIN SAMPLES WERE EVALUATED. BOTH LOTS MET PRODUCT SPECIFICATIONS FOR ADHESIVE STRENGTH. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES FROM THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINTS WERE RECEIVED FOR EITHER LOT WHICH INDICATES THAT THIS INCIDENT WAS AN ISOLATED INCIDENT. THESE INVESTIGATION RESULTS SHOW THAT THE DEBONDS WERE LIKELY THE RESULT OF A USER OR TECHNIQUE-RELATED PROBLEM AND NOT TO A PRODUCT FAILURE. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED THAT FIVE (5) PATIENTS LOST A CROWN THAT HAD BEEN PLACED WITH MAXCEM ELITE. THIS MDR IS THE FOURTH OF FIVE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R FUSION CURING LIGHT