BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3348040 · Received September 13, 2013

    Report

    Report Number
    2024312-2013-00466
    Event Type
    Injury
    Date Received
    September 13, 2013
    Report Date
    August 19, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S AGE, GENDER, AND WEIGHT WERE NOT PROVIDED. ALTHOUGH THE OFFICE IDENTIFIED SIX (6) DIFFERENT LOTS ASSOCIATED WITH THE BLACK SPECKS, THE OFFICE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 3722339, 4567016, 4775268, 4807843, 4252347, AND 4814789. THE OFFICE COULD NOT RECALL SPECIFIC PATIENT OR INCIDENT DETAILS. THE DOCTOR DRILLED OUT THE RESTORATION AND REPLACED IT USING A DIFFERENT PRODUCT DURING THE SAME OFFICE VISIT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT FOR EACH OF THE ALLEGED LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT BETWEEN SIX (6) DIFFERENT LOTS OF SONICFILL COMPOSITE, BLACK SPECKS WERE PRESENT IN FIVE (5) PATIENT'S RESTORATIONS AFTER LIGHT CURING THE MATERIAL. THIS IS THE FIRST OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461580 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R