BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPS ERIS FOR E2

    MDR report key: 2105331 · Received May 4, 2011

    Report

    Report Number
    9612352-2011-00005
    Event Type
    Other
    Date Received
    May 4, 2011
    Date of Event
    January 1, 2006
    Report Date
    May 3, 2011
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EIH
    PMA / PMN Number
    K012174
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    TEETH 13-23 WERE RESTORED WITH IPS ERIS FOR E2 CERAMIC IN 2004 AND, SINCE 2006, THE CERAMIC APPEARED TO GET ROUGHER. A PHOTOGRAPH SENT BY THE DENTIST REVEALS SOFT TISSUE CHANGES AND APPEARS TO BE AN OPULIS FIBROMATOSA, A REACTIVE FIBROUS HYPERPLASIA OF THE GINGIVA. THIS COULD HAVE BEEN CAUSED BY CHRONIC INFLAMMATION OR MICROTRAUMA. IT IS LIKELY THAT THE SOFT TISSUES MUST BE SURGICALLY TREATED AND THE RESTORATION REPLACED. THE CELL GROWTH SHOULD BE ANALYZED WITH A BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPS ERIS FOR E2 DENTAL PORCELAIN EIH IVOCLAR VIVADENT AG 575677 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other