BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 3873714 · Received September 24, 2013

    Report

    Report Number
    9612352-2013-00011
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    September 11, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO RISK TO PATIENT HEALTH. EXCITE F DSC IS A DUAL CURING ADHESIVE AND THEREFORE USUALLY USED IN CLINICAL SITUATIONS WHERE THE RESTORATION IS SOMEWHAT OPAQUE. THIS ALSO APPLIES IN THE ENDODONTIC INDICATION. IN THESE CASES A POSSIBLE 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/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 CORRECTION ACTION TO REMOVE (B)(4) 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
    483063 EXCITE F DSC AGENT TOOTH BONDIG RESIN, PRODUCT CODE: KLE KLE IVOCLAR VIVADENT AG R59595

    Patients

    Seq Age Sex Outcome Treatment
    1