BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 2083498 · Received May 10, 2011

    Report

    Report Number
    2024312-2011-00173
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE IDENTIFIED LOTS WERE RETURNED TO KERR CORPORATION FOR EVALUATION; THEREFORE, RETAIN SAMPLES WERE TESTED AND MET SPECIFICATIONS FOR ADHESIVE STRENGTH. A REVIEW OF THE MANUFACTURING RECORDS FOR EACH OF THE THREE IDENTIFIED LOTS INDICATED THAT THERE WERE NO NON-CONFORMANCES OR VARIANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A REVIEW OF COMPLAINT DATABASE TRENDING FOR EACH LOT SHOWED THAT NO SIMILAR COMPLAINTS WERE RECEIVED. THESE INVESTIGATION RESULTS HAVE LED TO THE CONCLUSION THAT THE ALLEGED DEBOND WAS AN ISOLATED INCIDENT AND WAS NOT THE RESULT OF A PRODUCT FAILURE. THE DOCTOR WAS UNABLE TO PROVIDE INFORMATION ON THE CURRENT HEALTH CONDITION OF THE AFFECTED PATIENT. HE DID, HOWEVER, DISCLOSE THAT A DIFFERENT PRODUCT WAS USED FOR RE-CEMENTATION. TESTED RETAIN SAMPLES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR ALLEGED THAT FORTY (40) PATIENTS EXPERIENCED THE DEBONDING OF CROWNS INITIALLY PLACED WITH MAXCEM ELITE. THE DOCTOR IDENTIFIED THREE LOTS OF MAXCEM ELITE THAT WERE IN USE AT THE TIME THE DEBONDS OCCURRED; HOWEVER, HE WAS UNABLE TO PROVIDE THE NUMBER OF PATIENTS AFFECTED BY EACH LOT. THIS MDR IS THE FORTIETH OF FORTY 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