BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIOLINK II

    MDR report key: 1902707 · Received November 1, 2010

    Report

    Report Number
    9612352-2010-00003
    Event Type
    Other
    Date Received
    November 1, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 26, 2010
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EBF
    PMA / PMN Number
    K971372
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DENTIST SUPPLIED THREE PHOTOS, WHICH SHOW AN INFLAMMATION OF THE GINGIVA CLOSE TO THE FRESHLY TREATED TEETH. THE GINGIVA MARGIN SEEMS SWOLLEN. THE PAPILLAE ARE COMPLETELY RETRACTED. IT CANNOT BE EXCLUDED THAT THE MENTIONED PHENOMENA ARE AN ALLERGIC REACTION. THERE IS NO INFORMATION ABOUT THE CURING TREATMENT AND NO PROOF THAT THE COMPOSITE HAS BEEN CURED PROPERLY. A POSSIBLE REASON FOR THE OBSERVED RESPONSE OF THE GINGIVA TISSUE COULD BE THE PRESENCE OF CURED EXCESS LUTING COMPOSITE. THIS EXCESS MATERIAL COULD IRRITATE THE NEIGHBORING TISSUE AND LEAD TO INFLAMMATION.

    Description of Event or Problem · 1

    A (B)(6) WOMAN REQUESTED AESTHETIC TREATMENT TO ACQUIRE A PERMANENT WHITE SMILE AND A MORE SYMMETRICAL DENTAL ARCH. IPS E.MAX PRESS WAS USED TO PREPARE VENEERS AND THESE WERE CEMENTED WITH VARIOLINK II. THE PATIENT RETURNED TO THE DENTIST AFTER 3 DAYS WITH SYMPTOMS OF ACUTE GINGIVITIS. THE TEETH WERE CLEANED ULTRASONICALLY IN THE DENTAL PRACTICE AND THE PATIENT ASKED TO RETURN AFTER 1 WEEK. AT THE NEXT VISIT, THE DENTIST SAW THAT THE SITUATION HAD GOT WORSE AND CONCLUDED SHE WAS SUFFERING FROM HYPERPLASTIC GINGIVITIS. HE GAVE HER ANTIBIOTICS, ANESTHESIA AND MOVED ON TO A THOROUGH TREATMENT OF GINGIVITIS. THE NEXT REVIEW SHOWED STABILITY. ONE MONTH LATER, THE DENTIST DIAGNOSED SYMPTOMS OF NECROTIZING STOMATITIS IN THE REGION OF THE TWO UPPER CANINES (13 AND 23) WHERE THE MUCOSA WAS IN DIRECT CONTACT WITH THE RESTORATION. AFTER A FURTHER 3 MONTHS, THE SITUATION WAS STILL NOT AS EXPECTED AS THE VENEERS HAVE BEEN OR WILL BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIOLINK II DENTAL CEMENT EBF IVOCLAR VIVADENT AG 628322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other