BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE F DSC

    MDR report key: 5663648 · Received September 17, 2013

    Report

    Report Number
    9612352-2013-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    September 6, 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

    ADDITIONAL QUALITY CONTROL MONITORING. ACTUAL MATERIAL WAS USED BY DENTIST. THERE WERE 91 REFILL PACKS (50 APPLICATIONS PER REFILL) W/BATCH (B)(4) SUPPLIED TO CUSTOMERS WORLDWIDE FROM (B)(6) 2012. BASED ON TYPICAL STOCK TURNOVER AND OUR PRODUCTION SCHEDULE OVER THE LAST 12 MONTHS WE ESTIMATE THAT THE MAJORITY OF CUSTOMERS HAVE ALREADY USED THEIR MATERIAL. 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 THE FRONT OF THE MOUTH. HOWEVER, EVEN HERE, THE AESTHETICS ARE ONLY AFFECTED WHEN THE CERAMIC IS VERY THIN. BASED ON THIS ASSESSMENT - THAT MATERIAL HAS ALREADY BEEN USED AND THERE IS NO RISK TO PATIENT HEALTH, NO FIELD SAFETY ACTION IS PLANNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DENTIST CEMENTED A CROWN USING VARIOLINK II TRANSPARENT CEMENT AND EXCITE F DSC DENTIN ADHESIVE. IN (B)(6) THEY REPORTED THAT THE CROWN APPEARED TO HAVE A BLUISH APPEARANCE. IT WAS REMOVED AND FOUND THAT THE DENTIN ALSO HAD A BLUISH APPEARANCE. A NEW CROWN WAS CEMENTED WITH A DIFFERENT CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469301 EXCITE F DSC KLE IVOCLAR VIVADENT AG 630378AN R59595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention