BEUDAMED
    FDA Adverse Event Summary report: N

    TELIO CS LINK

    MDR report key: 6001542 · Received October 5, 2016

    Report

    Report Number
    9612352-2016-00005
    Date Received
    October 5, 2016
    Date of Event
    March 4, 2015
    Report Date
    August 17, 2016
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EMA
    PMA / PMN Number
    K042846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTS THAT 6-7 PATIENTS AS WELL AS 2 STAFF MEMBERS COMPLAIN OF SEVERE SENSITIVITY AFTER USING THE CEMENT. THERE WERE SEVERAL PATIENTS IN WHICH THE CEMENT WAS USED AS WELL HOWEVER WITH NO REACTION. EACH PATIENT SHOWED A PULPAL REACTION TO THE CEMENT. IN EACH COMPLAINT CASE, THE PATIENT COMPLAINED OF A LOT OF PAIN. A TOTAL OF 3 COMPLAINTS WERE RECEIVED: (B)(4) FROM THE SAME DENTIST. ONLY ONE PATIENT RESULTED IN A ROOT CANAL THERAPY RECOMMENDED BY A DIFFERENT/NEW DENTIST. IN THE OTHER PATIENTS THE PAIN CEASED ONCE THE PROVISIONAL RESTORATION AND CEMENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651481 TELIO CS LINK CEMENT, DENTAL EMA IVOCLAR VIVADENT AG T35331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other