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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Malaise (2359)

Event Type  Injury  

Event Description

A doctor alleged that the realseal treatment in root canals for multiple patients had failed and the patients had experienced general malaise, infections, and required root canal retreatments.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided.The doctor reported that multiple patients had returned anywhere from six (6) months to two (2) years after the initial root canal procedure had been completed due to failure of the realseal treatment.The doctor retreated the root canals and prescribed antibiotics and/or painkillers for treatment.Over-the-counter treatments such as ibuprofen or tylenol were also recommended.To date, each of the patients have fully recovered and are 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: 3802729
• MDR Text Key: 4526696
• Report Number: 2016150-2014-00101
• 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: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• 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: 04/29/2014
• 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