BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 3370356 · Received September 26, 2013

    Report

    Report Number
    2024312-2013-00563
    Event Type
    Injury
    Date Received
    September 26, 2013
    Report Date
    August 28, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH DEBONDING OF RESTORATIONS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4901812, 4852230, AND 4444980. PATIENT SPECIFICS AGE AND GENDER WAS NOT PROVIDED. THE DOCTOR RE-CEMENTED OR REPAIRED THE RESTORATION FOR THE PATIENT WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS FINE. A 'ROCKWELL HARDNESS' TEST OF THE RETURNED PRODUCT WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FIVE (5) PATIENTS HAD EXPERIENCED A DEBONDING AND CHIPPING OF RESTORATIONS AFTER USING HERCULITE ULTRA. THIS IS THE FIRST OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486362 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other