BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 4025331 · Received August 20, 2014

    Report

    Report Number
    2024312-2014-00540
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 24, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) SHADES ASSOCIATED WITH THE BLACK SPECKS, 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 4859240 AND 4874468. SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE DOCTOR REMOVED THE SONICFILL RESTORATION AND REPEATED THE PROCEDURE DURING THE SAME VISIT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, AN APPEARANCE TEST OF THE RETAIN SAMPLE WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT SIX (6) PATIENTS HAD EXPERIENCED THE BLACK SPECKS WITHIN THEIR RESTORATIONS AFTER LIGHT CURING WITH THE SONICFILL MATERIAL. THIS IS THE FIFTH OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502139 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R