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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A doctor's office alleged that multiple patients had experienced root canal treatment failures due to the realseal product.

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 first of two hundred fifty (250) reports.

Manufacturer Narrative

Specific information with regard to the number of patients involved, genders, ages, and weights has not yet been determined.An update will be provided if any new information is provided by the office.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.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight could not be recalled.It was revealed that the actual product involved in the alleged incident was realseal se; therefore, a correction was made reflecting the correct device name and 510(k) number.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: 3830966
• MDR Text Key: 4502919
• Report Number: 2016150-2014-00179
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

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?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 05/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2014
• 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