BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACAL XS

    MDR report key: 7191190 · Received January 15, 2018

    Report

    Report Number
    1718912-2017-00041
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    October 21, 2015
    Report Date
    December 21, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC
    Product Code
    EJK
    PMA / PMN Number
    K970114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINS OF LOT BB5B2 WERE TESTED AND FOUND THE PRODUCT TO MEET SPECIFICATIONS. EXPRESSING THROUGH THE APEX DURING ROOT CANAL THERAPY CAN HAPPEN. REPORTED DUE TO THE FACT THE PATIENT WAS GIVEN MEDISTEROL, (STEROID PACK) TO REDUCE INFLAMATION, THIS IS REPORTABLE PER 21 CFR 803. PATIENT STARTED THE STEROID AND WAS MONITORED. ULTRACAL WILL RESORB OVER TIME. IN HOUSE CLINICAN SUGGESTED TO BRING PATIENT BACK FOR AN XRAY IN 7-10 DAYS.

    Description of Event or Problem · 1

    DR STATED HE EXPRESSED SOME ULTRACAL PASSED THE APEX OF THE TOOTH #29. HE PROCEEDED TO FINISH THE ROOT CANAL THERAPY. IT APPEARED THAT THE ULTRACAL MAY HAVE VIOLATED THE INFERIOR AVELAR NERVE SPACE. THE PATIENT IS REPORTED A BURNING SENSATION IN THE CORNER OF HIS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35218 ULTRACAL XS CALCIUM HYDROXIDE CAVITY LINER EJK ULTRADENT PRODUCTS INC BB5B2

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other