BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3362917 · Received September 23, 2013

    Report

    Report Number
    2024312-2013-00472
    Event Type
    Injury
    Date Received
    September 23, 2013
    Report Date
    August 29, 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

    ALTHOUGH THE DOCTOR IDENTIFIED FOUR (4) DIFFERENT LOTS ASSOCIATED WITH THE BLACK SPECKS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDED LOT NUMBERS 4646817, 4252080, 3851620, AND 4832210. SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE, GENDER AND WEIGHT WAS NOT PROVIDED. THE OFFICE COULD NOT RECALL PATIENT OR INCIDENT DETAILS. THE OFFICE REPORTED THAT THE DOCTOR HAD TO REMOVE THE PATIENT'S RESTORATION AND REPEATED THE PROCEDURE DURING THE SAME OFFICE VISIT. TO DATE, THE PATIENT IS DOING FINE. FOR LOT NUMBERS 4252080 AND 4832210, A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT FROM EACH LOT, YIELDING RESULTS WITHIN SPECIFICATIONS. FOR LOT NUMBERS 4646817 AND 3851620, THE PRODUCT WAS NOT RETURNED; THEREFORE, A VISUAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM EACH LOT, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY FIVE (5) PATIENTS HAD EXPERIENCED BLACK SPECKS IN THEIR RESTORATION AFTER LIGHT CURING THE SONICFILL MATERIAL. THIS IS THE SECOND OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479061 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R