BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIOLINK II

    MDR report key: 2026780 · Received March 21, 2011

    Report

    Report Number
    9612352-2011-00002
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    November 30, 2010
    Report Date
    February 17, 2011
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EBF
    PMA / PMN Number
    K971372
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST DID NOT PROVIDE ANY FURTHER WRITTEN INFO CONCERNING BATCH NUMBER, BONDING SYSTEM, TREATMENT STEPS, ETC. AND NO DEVICE ANALYSIS COULD TAKE PLACE. POSTOPERATIVE SENSITIVITIES CAN HAVE VARIOUS CAUSES: TYPE OF PREPARATION, BITE PROBLEMS BY INCORRECT ARTICULATION, INSUFFICIENT POLYMERIZATION, INADEQUATE SEALING OF THE DENTINE, INDIVIDUAL PT CHARACTERISTICS. POSTOPERATIVE SENSITIVITY CAN ALSO OCCUR AFTER LEGE ARTE TREATMENT BUT USUALLY SENSITIVITY IS GONE AFTER A FEW WEEKS. IN THIS CASE, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    AFTER CEMENTING RESTORATIONS WITH VARIOLINK II, POST OPERATIVE SENSITIVITIES OCCURRED. APPARENTLY, THIS RESULTED IN A LEAST ONE TOOTH BECOMING DEVITALIZED AND REQUIRING ROOT CANAL TREATMENT. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other