BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIOLINK VENEER

    MDR report key: 6456204 · Received April 4, 2017

    Report

    Report Number
    9612352-2017-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Report Date
    March 27, 2017
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EBF
    PMA / PMN Number
    K901917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT THE MATERIAL DID NOT POLYMERIZE PROPERLY WHEN USED WITH THE BLUEPHASE STYLE CURING LIGHT. DUE TO A DARKENING UNDER THE CROWNS (MICROLEAKAGE), THE HEALTH CARE PROFESSIONAL HAD TO CUT OFF ALL OF THE RESTORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241022 VARIOLINK VENEER MATERIAL, TOOTH SHADE, RESIN EBF IVOCLAR VIVADENT AG U33189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other