BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPS E.MAX CAD

    MDR report key: 4297330 · Received October 20, 2014

    Report

    Report Number
    9612352-2014-00003
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    September 2, 2014
    Report Date
    October 13, 2014
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    NHA
    PMA / PMN Number
    K132209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PHOTOS AND THE INSPECTION OF THE RESTORATION THE GAP BETWEEN THE TITANIUM ABUTMENT AND THE CERAMIC SUPRASTRUCTURE SEEMS SMOOTH. THER ARE NO REMNANTS OF EXCESS LUTING MATERIAL. THE SO CALLED CEMENT GAP IS NOT EXTRAORDINARILY WIDE. THE USE OF SURGILUB TO AVOID THE FORMATION OF AN OXYGEN INHIBITION LYER INSTEAD OF LIQUID STRIP IS NOT RECOMMENDED. THERE ARE SOME CONTROVERSIES WHETHER THE PRESENCE OF CHLORHEXIDINE INHIBITS THE CURING OF THE LUTING MATERIAL. IT IS JUST A HYPOTHESIS THAT THIS MAY BE CAUSE OF THE FISTULA. ONE PHOTO SHOWS THE ACCESS TO THE IMPLANT. IT IS RATHER OBVIOUS THAT THE RESTORATION WAS INSERTED VERY DEEP IN THE GINGIVA. THE ACCESS IS VERY TIGHT. IT SEEMS RATHER OBVIOUS THAT TISSUE WAS TRAPPED (SQUEEZED) DURING SCREWING IN THE ABUTMENT. THIS COULD BE THE CAUSE OF THE FORMATION OF THE FISTULA. THIS COULD EXPLAIN THE OCCURRENCE IN TWO PTS INDEPENDENTLY. IT IS VERY UNLIKELY THAT THE RESTORATION OF THE RELATED MATERIALS ARE THE CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 1

    FISTULA FORMATION AT LEVEL OF JUNCTION OF TI-BASE AND IPSE.MAX CAD SCREW-RETAINED CROWN BONDED TOGETHER WITH MILTILINK HYBRID ABUTMENT CEMENT. GLYCERINE-BASED OXYGEN INHIBITOR (SURGILUBE) USED DURING CURE. FISTUAL OCCURRED AT THREE WEEKS POST PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668236 IPS E.MAX CAD ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA IVOCLAR VIVADENT AG LT D2 A16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention