BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 3820412 · Received November 27, 2013

    Report

    Report Number
    9612352-2013-00012
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    September 19, 2013
    Report Date
    October 15, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    381 REFILL PACKS (50 APPLICATIONS PER REFILL) WITH BATCH R59595 WERE SUPPLIED TO CUSTOMERS WORLDWIDE. THERE IS NO RISK TO PT 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 QC MONITORING HAS BEEN INTRODUCED, SO THAT EVERY BATCH IS CHECKED USING UV/VISUAL ANALYSIS. THE POSSIBILITY OF CHANGING THE MONOMER PRODUCTION PROCESS TO AVOID USING THIS STABILISER IS BEING INVESTIGATED. IT HAS BEEN DECIDED TO UNDERTAKE A FIELD SAFETY CORRECTIVE ACTION TO REMOVE BATCH R59595 FROM THE MARKET.

    Description of Event or Problem · 1

    THE DENTIST FOUND A BLUE DISCOLORATION OF CEMENT WHEN USING THE PRODUCT WITH VARIOLINK II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621243 EXCITE F DSC AGENT, TOOTH BONDING RESIN KLE IVOCLAR VIVADENT AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention