MAUDE Adverse Event Report: SYBRONENDO REALSEAL; 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 seventy-five (75) patients had experienced the failure and re-treatment of a root canal due to the realseal material.This is the fifty-third of seventy-five (75) reports.

Manufacturer Narrative

Patient specifics with regard to gender, age, and weight were not provided.Multiple attempts were made to contact the office on (b)(4) 2014 to obtain further incident information; however, the office has remained unresponsive.The doctor had e-mailed a response to sybronendo corporation on (b)(6) 2014 ; however, no patient or incident information was reported.Despite further follow-ups, no incident information has been received.An update will be provided if any further information regarding the alleged incidents is obtained.The product involved in the alleged incidents 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: 3815832
• MDR Text Key: 4499402
• Report Number: 2016150-2014-00156
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• 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: 04/17/2014
• 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