BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 5663570 · Received December 30, 2013

    Report

    Report Number
    9612352-2013-00014
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Report Date
    December 23, 2013
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    KLE
    PMA / PMN Number
    K093744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY INVESTIGATION SHOWS THAT A BLUE/GREEN DISCOLORATION OF EXCITE F DSC CAN OCCUR WHEN THE PRODUCT IS USED WITH A CEMENT CONTAINING BENZOYL PEROXIDE. THE DISCOLORATION IS CAUSED BY A STABILISER IN EXCITE F DSC WHICH IS PRESENT IN THE RANGE OF 10-50 PPM. THE SUSCEPTIBILITY TO DISCOLORATION COULD BE DETECTED ONLY IN BATCH R59595. THIS BATCH WAS PRODUCED IN AUGUST 2012 AND HAS AN EXPIRY DATE JANUARY 2015. RETAINED SAMPLES FROM OTHER BATCHES CONTAINING THE SAME BULK LIQUID WERE ALSO CHECKED BUT NO DISCOLORATION WAS EVIDENT. RETAINED SAMPLES OF PRODUCT MADE SINCE AUGUST 2012 WITH DIFFERENT BATCHES OF BULK LIQUID WERE TESTED AND NO DISCOLORATION WAS EVIDENT. A BLUE DISCOLORATION DOES NOT AFFECT THE FUNCTION OF EXCITE F DSC AND THERE IS NO BIOCOMPATIBILITY RISK. (B)(4) REFILL PACKS ((B)(4) APPLICATIONS PER REFILL) WITH BATCH R59595 WERE SUPPLIED TO CUSTOMERS WORLDWIDE. 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. 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 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 CORRECTIVE ACTION TO REMOVE BATCH R59595 FROM THE MARKET.

    Description of Event or Problem · 1

    THE DENTIST HAD TO REMOVE CROWN THAT WAS SEATED 1 MONTH BEFORE DUE TO GREEN/BLUE DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681562 EXCITE F DSC AGENT, TOOTH BONDING RESIN KLE IVOCLAR VIVADENT AG R59595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention