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

Device Problem Degraded (1153)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was alleged that multiple patients had required root canal retreatment due to the degradation of the realseal material.This is the second of three (3) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight was not provided.The patient had experienced the degradation of realseal material in the canal which the doctor reported had led to the formation of lesions which required a repeat root canal procedure and antibiotics for treatment.The patient had also experienced a pink discoloration of the tooth from the realseal material.The doctor bleached the patient's tooth to remove the discoloration.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.

• 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: 3767670
• MDR Text Key: 4360095
• Report Number: 2016150-2014-00099
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102163
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• 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: 04/08/2014
• 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