BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE XRV

    MDR report key: 3881399 · Received June 18, 2014

    Report

    Report Number
    2024312-2014-00429
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K943642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE VOIDS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 5045224 AND 4951193. THE DOCTOR CUT OUT THE COMPOSITE FOR TEETH #4 AND #6 AND REFILLED THE PREPS AGAIN USING THE SAME PRODUCT. THE DOCTOR TOOK ANOTHER X-RAY AND VOIDS AND OPEN MARGINS APPEARED; HOWEVER, THE DOCTOR WAS CERTAIN THAT NO VOIDS OR OPEN MARGINS WERE PRESENT. THE PATIENT DID NOT WANT THE DOCTOR TO RE-DO THE RESTORATION. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WERE NOT RETURNED; THEREFORE, A VOID TEST WAS PERFORMED ON THE RETAIN SAMPLES FOR LOTS 5045224 AND 4951193, 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 VOIDS AND OPEN MARGINS APPEARED ON X-RAYS AFTER PLACEMENT OF THE HERCULITE XRV COMPOSITE FOR TWO (2) PATIENTS. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357986 HERCULITE XRV MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R