BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3786775 · Received May 2, 2014

    Report

    Report Number
    2024312-2014-00276
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    April 3, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFIC WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR PROVIDED THREE (3) DIFFERENT SHADES ASSOCIATED WITH THE VOIDS, 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 4931574, 4931579, AND 4931576. THE DOCTOR COULD NOT RECALL PATIENT OR INCIDENT DETAIL. TO DATE, THE PATIENT IS DOING FINE. THE DOCTOR DRILLED OUT THE RESTORATION AND REDID THE PROCEDURE USING THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. AN 'EXTRUSION' AND 'VOID CONCENTRATION' TESTS OF THE RETURNED PRODUCT WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED 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'S OFFICE ALLEGED THAT TWO (2) PATIENTS HAD EXPERIENCED VOIDS WITHIN THEIR RESTORATIONS AFTER PLACEMENT WITH SONICFILL COMPOSITE. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265974 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R