BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 4210670 · Received October 29, 2014

    Report

    Report Number
    2024312-2014-00652
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO WEIGHT WAS NOT PROVIDED. THE DOCTOR DRILLED OUT THE COMPOSITE AND REPEATED THE PROCEDURE DURING THE SAME OFFICE VISIT USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION OF THE RETAIN SAMPLE 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 THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT BLACK SPECKS WERE PRESENT IN THE SONICFILL COMPOSITE MATERIAL DURING THREE (3) PATIENTS' RESTORATION PROCEDURE. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692731 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION 5044581

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R