BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3881742 · Received June 18, 2014

    Report

    Report Number
    2016150-2014-00182
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 28, 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 EXPERIENCED THE RETREATMENT OF A FAILED REALSEAL ROOT CANAL. THE INITIAL TREATMENT DATE WAS NOT PROVIDED; HOWEVER, THE PATIENT'S FINAL ROOT CANAL RETREATMENT HAD BEEN COMPLETED ON (B)(6) 2014. THE DOCTOR HAD REMOVED A BLACK SUBSTANCE FROM THE CANAL AND THEN FILLED IT WITH CALCIUM HYDROXIDE FOR TREATMENT. THE PATIENT HAD RETURNED FOR A ROUTINE CLEANING APPOINTMENT ON (B)(6) 2014 AND IT WAS NOTED THAT THE PATIENT WAS DOING FINE. THE PATIENT IS SET TO RETURN TO THE OFFICE FOR A FINAL ROOT CANAL CHECK-UP; HOWEVER, AN EXACT DATE WAS NOT PROVIDED. AN UPDATE WILL BE PROVIDED IF ANY FURTHER INFORMATION IS OBTAINED WITH REGARD TO THE PATIENT'S HEALTH STATUS. 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 THIRTEENTH OF FIFTEEN (15) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357905 REALSEAL GUTTA-PERCHA EKM SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R