BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 3812573 · Received May 15, 2014

    Report

    Report Number
    2016150-2014-00102
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K102163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE OFFICE ON (B)(6) 2014 TO OBTAIN FURTHER INCIDENT INFORMATION; HOWEVER, THE OFFICE HAS REMAINED UNRESPONSIVE. THE DOCTOR DID CONTACT ON (B)(6) 2014 AND REPORTED THAT MULTIPLE PATIENTS HAD EXPERIENCED ROOT CANAL FAILURES SINCE 2008 IN ADDITION TO THE ONE (1) PATIENT REPORTED ON (B)(6) 2014; HOWEVER, NO FURTHER SPECIFIC PATIENT OR INCIDENT INFORMATION WAS ABLE TO BE OBTAINED. DESPITE FURTHER FOLLOW-UPS, NO INCIDENT INFORMATION HAS BEEN RECEIVED. AN UPDATE WILL BE PROVIDED IS ANY FURTHER INFORMATION REGARDING THE INCIDENT IS OBTAINED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER OR CATALOG NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR INITIALLY ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED A ROOT CANAL FAILURE DUE TO THE REALSEAL MATERIAL; HOWEVER, DURING A FOLLOW UP PHONE CALL ON (B)(6) 2014, THE DOCTOR ALLEGED THAT MULTIPLE PATIENTS HAD EXPERIENCED ROOT CANAL FAILURES SINCE 2008 DUE TO THE REALSEAL PRODUCT. TWO (2) REPORTS WILL BE SUBMITTED WITH REGARD TO THE ALLEGED INCIDENTS. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290938 REALSEAL RESIN, ROOT CANAL FILLING KIF SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R