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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor alleged that two (2) patients had required endodontic re-treatment for root canals that had previously been filled with epiphany.This is the first of two (2) reports.

Manufacturer Narrative

Specific patient information such as age and weight was not provided.The doctor reported that the initial root canal treatment was performed approximately five (5) years ago by a different endodontist and that epiphany root canal sealant material had been used for the initial procedure.The doctor diagnosed the tooth with a par lesion associated with the palatal root.The doctor cleaned the affected root canals in the patient's tooth, packed it with calcium hydroxide, and prescribed antibiotics for treatment.The doctor reported that black material was found within the root canal during re-treatment and removal of the epiphany material.The patient will return to the office at a later date for completion of the root canal procedure.At this time, the patient is doing fine.Sybronendo has requested that the customer report any new information with regard to this patient.An update will be provided if any new information becomes available.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted.Upon the 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 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 the medical intervention for retreatment.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: EPIPHANY
• 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: 4438981
• MDR Text Key: 5387394
• Report Number: 2016150-2015-00001
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2014
• 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