MAUDE Adverse Event Report: SYBRONENDO REALSEAL; RESIN, ROOT CANAL FILLING

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

On (b)(6) 2014, a dealer representative had contacted sybronendo with a complaint from the doctor alleging that the realseal treatment in root canals for multiple patients had failed and the patients had experienced pain, infection, and required root canal retreatment.No further information was able to be obtained at that time.On (b)(6) 2014, the doctor provided an update and reported that seventy (70) patients had experienced the retreatment of a root canal due to a breakdown of the realseal material.This is the sixty-sixth of seventy (70) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight was not provided.The patient had experienced an infection and the presence of black material in the canal which required a repeat root canal procedure and antibiotics for treatment of the infection.To date, the patient is doing fine.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.Upon further investigations 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 the bismuth sulfide are primarily due to technique variations and deviations from the instructions for use of the realseal system, and include 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.

• Brand Name: REALSEAL
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: kerri casino ; 1717 w. collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3759337
• MDR Text Key: 4553639
• Report Number: 2016150-2014-00093
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention