BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 4153027 · Received October 8, 2014

    Report

    Report Number
    2024312-2014-00632
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) SHADES ASSOCIATED WITH THE BLACK SPECKS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 5044580, 4819811, AND 4814790. THE DOCTOR DRILLED OUT THE COMPOSITE AND REPEATED THE PROCEDURE DURING THE SAME OFFICE VISIT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT FROM EACH OF THE LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FIVE (5) PATIENTS HAD EXPERIENCED THE PRESENCE OF BLACK SPECKS WITHIN THEIR SONICFILL RESTORATIONS AFTER LIGHT CURING THE COMPOSITE. THIS IS THE SECOND OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631777 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R