BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL

    MDR report key: 2271032 · Received September 30, 2011

    Report

    Report Number
    2016150-2011-00174
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2011
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K011748
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS RETREATED WITH GUTTA PERCHA AND IS DOING FINE. UPON FURTHER INVESTIGATION OF PREVIOUS COMPARABLE INCIDENTS, IT WAS FOUND THAT THE BLACK MATERIAL SEEN WITHIN THE PRODUCT WAS BISMUTH SULFIDE. IT IS PRODUCED BY THE REACTION BETWEEN BISMUTH OXYCHLORIDE IN THE REALSEAL ROOT CANAL FILLER AND A PROTEIN (MOST LIKELY FROM A BODILY FLUID). THE POSSIBLE CAUSES FOR THE FORMATION OF BISMUTH SULFIDE ARE PRIMARILY DUE TO TECHNIQUE VARIATIONS AND DEVIATIONS FROM THE INSTRUCTIONS FOR USE OF THE REALSEAL SYSTEM. THIS INCLUDES OVERHEATING AND INCOMPLETE FLUSHING OF NAOCL FROM THE ROOT CANAL. OVERHEATING CAN DEGRADE THE REALSEAL CANAL FILLER AND POSSIBLY LEAD TO IMPROPER SEALING AND LEAKING, WHICH CAN RESULT IN THE LEECHING OF PROTEINS INTO THE ROOT CANAL AND SUBSEQUENT BISMUTH SULFIDE FORMATION. FAILURE TO COMPLETELY FLUSH ALL NAOCL FROM THE ROOT CANAL CAN ALSO RESULT IN THE FORMATION OF BISMUTH SULFIDE. RETREATMENT OF PATIENTS' ROOT CANALS IS REQUIRED TO REMOVE BISMUTH SULFIDE. THIS MDR IS BEING SUBMITTED BECAUSE OF THIS MEDICAL INTERVENTION. THE PREVIOUS INVESTIGATIONS LED TO THE CONCLUSION THAT THE PRODUCT ITSELF, WHEN USED ACCORDING TO THE INSTRUCTIONS FOR USE, PERFORMS AS INTENDED AND YIELDS ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR ALLEGED THAT A RETREAT OF A REALSEAL OBTURATION WAS REQUIRED BECAUSE BLACK MATERIAL WAS SEEN WITHIN THE PATIENT'S ROOT CANAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R