BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 5663573 · Received December 20, 2013

    Report

    Report Number
    9612352-2013-00013
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    July 12, 2013
    Report Date
    December 20, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IN CLINICAL SITUATION 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 APPLIED IN THE ENDODONTIC INDICATION. A BLUE DISCOLORATION CAN BE NOTICEABLE IN TRANSLUCENT RESTORATION (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 EVER BATCH IS CHECKED USING UV/VISUAL ANALYSIS. THE POSSIBILITY OF CHANGING THE MONOMER PRODUCTION PROCESS TO AVOID USING THE STABILIZER 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
    670994 EXCITE F DSC AGENT, TOOTH BONDING RESIN KLE IVOCLAR VIVADENT AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention