BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 4006826 · Received August 13, 2014

    Report

    Report Number
    2024312-2014-00575
    Event Type
    Injury
    Date Received
    August 13, 2014
    Report Date
    August 4, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. THE PATIENT HAD EXPERIENCED SENSITIVITY AND THE DOCTOR REPLACED THE RESTORATIONS USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT.. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE DOCTOR'S OFFICE HAD INITIALLY ALLEGED THAT FOR AN UNKNOWN LOT NUMBER OF SONICFILL, APPROXIMATELY SEVEN (7) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT; HOWEVER, SPECIFIC PATIENT OR INCIDENT INFORMATION COULD NOT BE RECALLED. DURING A FOLLOW UP PHONE CALL ON 08/13/14, IT WAS DISCOVERED THAT TWO (2) ADDITIONAL LOT NUMBERS 5044576 AND 5091596 WERE ALSO ASSOCIATED WITH THE ALLEGED INCIDENT. ALTHOUGH THE OFFICE IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE SENSITIVITY, THE OFFICE COULD NOT VERIFY WHICH LOT WAS USED ON ANY OF THE PATIENTS. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT FROM THE TWO (2) PROVIDED LOTS #5044576 AND #5091596, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW 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'S OFFICE ALLEGED THAT APPROXIMATELY SEVEN (7) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT OF A RESTORATION USING THE SONICFILL PRODUCT. THIS IS THE THIRD OF SEVEN (7) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482490 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PRIME & BOND