BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3667347 · Received March 7, 2014

    Report

    Report Number
    2016150-2014-00016
    Event Type
    Injury
    Date Received
    March 7, 2014
    Report Date
    February 12, 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 PRODUCTS INVOLVED IN THE ALLEGED INCIDENTS WERE RETURNED AND A VISUAL EVALUATION WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    PATIENT'S SPECIFIC WITH REGARD TO AGE, WEIGHT AND GENDER WAS NOT PROVIDED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE DOCTOR REMOVED THE MATERIAL, CLEANSED THE AREA, AND PLACED CALCIUM HYDROXIDE FOR THREE (3) MONTHS. TO DATE, THE PATIENT IS STILL RECEIVING TREATMENTS. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR HAD INITIALLY ALLEGED THAT MORE THAN TEN (10) PATIENTS HAD EXPERIENCED ROOT CANAL FAILURES AFTER ENDODONTIC TREATMENT WITH REALSEAL; HOWEVER, ON (B)(6) 2014, THE OFFICE PROVIDED FURTHER INFORMATION AND 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 SIXTH OF FIFTEEN (15) REPORTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT MORE THAN TEN (10) PATIENTS HAD EXPERIENCED ROOT CANAL FAILURES AFTER ENDODONTIC TREATMENT WITH REALSEAL. THIS IS THE SIXTH OF ELEVEN (11) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140717 REALSEAL GUTTA-PERCHA EKM SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R