BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACAL XS

    MDR report key: 10070882 · Received May 19, 2020

    Report

    Report Number
    1718912-2019-00002
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    August 8, 2017
    Report Date
    December 18, 2019
    Manufacturer
    ULTRADENT PRODUCTS, INC
    Product Code
    EJK
    PMA / PMN Number
    K970114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN WIDELY KNOWN SINCE AT LEAST 1920 THAT CALCIUM HYDROXIDE HAS GREAT HEALING POWERS IN THE TOOTH DUE TO ITS HIGH PH, WHICH KILLS MICROORGANISMS IN TEETH AND ITS BIOACTIVITY TO REGENERATE TOOTH AT THE APEX. IN THIS CASE, BASED ON THE INFORMATION RECEIVED THUS FAR IN THE LITIGATION, THE GROSS OVER EXTRUSION OF ULTRACAL (CALCIUM HYDROXIDE) PAST THE APICAL FORAMEN IN A LOWER FIRST MOLAR RESULTED IN ALLEGED LONG-TERM PAIN, PARESTHESIA, AND EVENTUAL EXTRACTION OF THE INVOLVED TOOTH. HAVING THIS ALLEGED SEQUELAE HAPPEN AS A RESULT OF ROOT CANAL TREATMENT CAN HAPPEN, BUT IT IS DEFINITELY NOT THE STANDARD OF CARE IN ENDODONTICS TO HAVE THIS HAPPEN. IT HAS BEEN WELL KNOWN FOR ALL THESE YEARS. DENTISTS RECEIVE TRAINING IN DENTAL SCHOOL AND ANNUAL CONTINUING EDUCATION TRAINING THAT AN EXTRUSION (MISUSE) OF THIS CHEMICAL OUTSIDE THE CONFINES OF THE TOOTH MAY CAUSE THE PATIENT TO HAVE ISSUES SIMILAR TO THOSE ALLEGED TO HAVE OCCURRED HERE.

    Description of Event or Problem · 1

    PATIENT CLAIMS "BURNING AND NUMBNESS IN HIS LOWER LEFT FACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532456 ULTRACAL XS LINER CAVITY/CALICIUM HYDROXIDE EJK ULTRADENT PRODUCTS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other