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

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Event Description

On (b)(6) 2014, the doctor alleged that approximately two hundred fifty (250) patients had returned to the office due to pain and infection in root canals that had previously been treated with realseal se.This is the one hundred twenty-ninth of two hundred fifty (250) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight could not be recalled.The root canal failure occurred approximately six (6) months to one (1) year after treatment.The doctor stated that they cleaned out the root canal, filled it with calcium hydroxide, and may have prescribed codeine, amoxicillin, or clindamycin as treatment.The doctor reported that the patient either returned for 2-3 visits which involved canal cleaning and calcium hydroxide treatments, or the patient was referred out to an oral surgeon or periodontist for tooth removal and/or restorative work.The doctor was not definitive as to whether the patient had fully recovered.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.

• Brand Name: REALSEAL SE
• Type of Device: RESIN ROOT CANAL FILLING MATERIAL
• 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: 3896833
• MDR Text Key: 4673642
• Report Number: 2016150-2014-00313
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/26/2014
• 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