BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL POINTS

    MDR report key: 4071278 · Received September 9, 2014

    Report

    Report Number
    2016150-2014-00440
    Event Type
    Injury
    Date Received
    September 9, 2014
    Report Date
    August 12, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    EKM
    PMA / PMN Number
    K023819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE PRESENCE OF BLACK MATERIAL WITHIN THE CANAL, THE DOCTOR COULD NOT VERIFY WHICH LOT HAD BEEN USED ON ANY OF THE PATIENTS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS GE12110988, GE12101160, AND GE1111854. THE INITIAL ROOT CANAL PROCEDURE HAD TAKEN PLACE ON (B)(6) 2006. THE DOCTOR REPEATED THE ROOT CANAL PROCEDURE ON THE PATIENT'S TOOTH ON (B)(6) 2008 AND PRESCRIBED AMOXICILLIN FOR TREATMENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. PRIOR INVESTIGATIONS HAVE CONCLUDED THAT THE BLACK MATERIAL CAUSING THE DARKENING OF THE ROOT CANAL WAS BISMUTH SULFIDE, WHICH IS THE RESULT OF A REACTION BETWEEN THE BISMUTH OXYCHLORIDE IN THE REAL SEAL ROOT CANAL FILLER AND A PROTEIN (MOST LIKELY FROM A BODILY FLUID). THE POSSIBLE CAUSES FOR THE FORMATION OF THE BISMUTH SULFIDE ARE PRIMARILY DUE TO TECHNIQUE VARIATIONS AND DEVIATIONS FROM THE INSTRUCTIONS FOR USE OF THE REAL SEAL SYSTEM, AND INCLUDE OVERHEATING AND INCOMPLETE FLUSHING OF NAOCL FROM THE ROOT CANAL. OVERHEATING CAN DEGRADE THE REAL SEAL ROOT 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 THE BISMUTH SULFIDE. THIS MDR IS BEING SUBMITTED BECAUSE OF THIS MEDICAL INTERVENTION. THESE INVESTIGATIONS HAVE 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

    A DOCTOR'S OFFICE ALLEGED THAT FOR THE REALSEAL POINTS, TWENTY-SEVEN (27) PATIENTS HAD REQUIRED THE RE-TREATMENT OF A ROOT CANAL DUE TO THE PRESENCE OF BLACK MATERIAL WITHIN THE CANAL. THIS IS THE SECOND OF TWENTY-SEVEN (27) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554286 REALSEAL POINTS GUTTA-PERCHA EKM SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R