BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3141057 · Received June 3, 2013

    Report

    Report Number
    2024312-2013-00264
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED. THE PATIENT HAD EXPERIENCED THE LOSS OF A CROWN ON TOOTH #19 APPROXIMATELY TWO (2) DAYS AFTER PLACEMENT. THE DOCTOR CLEANED OUT THE CROWN AND RE-CEMENTED IT USING MAXCEM ELITE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE RETURNED PRODUCT WAS EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT. THESE INVESTIGATION RESULTS INDICATE THAT THIS INCIDENT IS AN ISOLATED INCIDENT THAT OCCURRED AS A RESULT OF A USER/TECHNIQUE RELATED ISSUE AND WAS NOT DUE TO A PRODUCT FAILURE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED THE LOSS OF A CROWN AFTER PLACEMENT WITH THE MAXCEM ELITE CLEAR PRODUCT. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245197 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION 4598253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R