BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3365836 · Received September 24, 2013

    Report

    Report Number
    2024312-2013-00512
    Event Type
    Injury
    Date Received
    September 24, 2013
    Report Date
    August 27, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED FOUR DIFFERENT LOTS ASSOCIATED WITH THE BLACK SPECKS, HE COULD NOT VERIFY WHICH LOT WAS USE ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDED LOT NUMBER 4252294, 4252405, 4252090 AND 4252403. SPECIFIC INFORMATION WITH REGARD TO AGE, GENDER AND WEIGHT WERE NOT PROVIDED. THE OFFICE COULD NOT RECALL PATIENT OR INCIDENT DETAILS. THE OFFICE REPORTED THAT THE DOCTOR HAD TO CUT OUT THE BLACK SPECKS AND REPEATED THE PROCEDURE DURING THE SAME OFFICE VISIT FOR THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WERE NOT RETURNED; THEREFORE, A 'VISUAL INSPECTION' OF THE RETAIN SAMPLES WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. THE PASTE APPEARED TO BE HOMOGENOUS AND FREE FROM CONTAMINATION. NO BLACK SPECKS WERE DETECTED. A DHR REVIEW FOR LOTS 4252294, 4252405, 4252090 AND 4252403 INDICATED 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 APPROXIMATELY SIXTY (60) PATIENTS HAD EXPERIENCED BLACK SPECKS IN THEIR RESTORATION AFTER LIGHT CURING THE SONICFILL MATERIAL. THIS IS THE TENTH OF SIXTY (60) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482485 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R