BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3881767 · Received June 18, 2014

    Report

    Report Number
    2016150-2014-00184
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    EKM
    PMA / PMN Number
    K023819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED NINETEEN (19) DIFFERENT LOTS ASSOCIATED WITH THE ROOT CANAL FAILURES, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON ANY OF THE PATIENTS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4813285, GE1112880, 148619, GE11121126, GE13070814, GE1106545, 179384, 196520, 190941, GE12081293, GE1208757, 171566, 179385, 190789, GE1208623, GE12021218, 121345101, 081349289, AND 011111998. THE PATIENT HAD RECEIVED A ROOT CANAL TREATMENT IN OCTOBER 2012 TO ADDRESS AN APICAL LESION. HE RETURNED TO THE OFFICE FOR A HYGIENE APPOINTMENT IN (B)(6) 2013 AND REPORTED PRESSURE SENSITIVITY; THEREFORE, AN X-RAY WAS TAKEN. THE DOCTOR NOTED THAT THE APICAL LESION HAD NOT HEALED. ON (B)(6) 2014 THE PATIENT RETURNED TO THE OFFICE AGAIN FOR A HYGIENE APPOINTMENT AND WAS STILL REPORTING PRESSURE SENSITIVITY; THEREFORE, ANOTHER X-RAY WAS TAKEN. THE APICAL LESION HAD STILL NOT HEALED; THEREFORE, THE DOCTOR RECOMMENDED ROOT CANAL RETREATMENT. NO APPOINTMENT HAS BEEN SET FOR THE RETREATMENT AT THIS TIME. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENTS WERE RETURNED AND A VISUAL EVALUATION WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT SINCE (B)(6) 2014, A TOTAL OF FIFTEEN (15) PATIENTS HAD EXPERIENCED ROOT CANAL RE-TREATMENT DUE TO ROOT CANAL FAILURES AFTER ENDODONTIC TREATMENT WITH REALSEAL. THIS IS THE FIFTEENTH OF FIFTEEN (15) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357137 REALSEAL GUTTA-PERCHA EKM SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R