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

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 05/20/2014

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced the failure of a root canal with what appeared to be the realseal material.

Manufacturer Narrative

Patient's specific with regard to age, weight and gender was not provided.The doctor started re-treating the lower first molar for the patient.Multiple attempts were made to contact the office on 05/30/14, 06/04/14, and 06/10/14 to obtain further incident information; however, the office has remained unresponsive.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: 3866528
• MDR Text Key: 4505486
• Report Number: 2016150-2014-00180
• 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: 05/20/2014

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: 05/20/2014
• Initial Date FDA Received: 06/11/2014
• 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