BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3881778 · Received June 18, 2014

    Report

    Report Number
    2016150-2014-00185
    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. 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. SPECIFIC PATIENT INFORMATION WITH REGARD TO EXACT NUMBER AFFECTED, GENDER, AGE, AND WEIGHT WAS NOT PROVIDED BY THE OFFICE. SYBRONENDO HAS REQUESTED THAT THE CUSTOMER REPORT ANY NEW INFORMATION WITH REGARD TO THESE PATIENTS. 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 MULTIPLE PATIENTS HAD BEEN DIAGNOSED WITH A FAILED ROOT CANAL AFTER ENDODONTIC TREATMENT WITH THE REALSEAL PRODUCT; HOWEVER, THEY HAVE NOT YET RECEIVED RETREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357425 REALSEAL GUTTA-PERCHA EKM SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R