BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 5663658 · Received September 19, 2013

    Report

    Report Number
    9612352-2013-00006
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Report Date
    September 18, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLE OF SAME LOT EVALUATED. THERE WERE (B)(4) REFILL PACKS ((B)(4) APPLICATIONS PER REFILL) W/BATCH (B)(4) SUPPLIED TO CUSTOMERS WORLDWIDE FROM (B)(6) 2012. BASED ON TYPICAL STOCK TURNOVER AND OUR PRODUCT SCHEDULE OVER THE LAST 12 MONTHS WE ESTIMATE THAT THE MAJORITY OF CUSTOMERS HAVE ALREADY USED THEIR MATERIAL. THERE IS NO RISK TO PATIENT'S HEALTH. EXCITE F DSC IS A DUAL CURING ADHESIVE AND THEREFORE USUALLY USED IN CLINICAL SITUATIONS WHERE THE RESTORATION IS SOMEWHAT OPAQUE. IN THESE CASES A POSSIBLE BLUE DISCOLORATION IS NOT VISIBLE AND DOES NOT AFFECT THE AESTHETICS OF THE RESTORATION. THIS ALSO APPLIES IN THE ENDODONTIC INDICATION. A BLUE DISCOLORATION CAN BE NOTICEABLE IN TRANSLUCENT RESTORATIONS (E.G. VENEERS) IN THE FRONT OF THE MOUTH. HOWEVER, EVEN HERE, THE AESTHETICS ARE ONLY AFFECTED WHEN THE CERAMIC IS VERY THIN. AN ADDITIONAL QUALITY CONTROL MONITORING HAS BEEN INTRODUCED SO THAT EVERY BATCH IS CHECKED USING UV/VIS ANALYSIS. THE POSSIBILITY OF CHANGING THE MONOMER PRODUCTION PROCESS TO AVOID USING THIS STABILISER IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE DENTIST FOUND THAT/EXCITE F DSC CHANGED COLOR TO GREEN SOON AFTER SEATING FINAL RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474729 EXCITE F DSC KLE IVOCLAR VIVADENT AG R59595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention