MAUDE Adverse Event Report: SYBRONENDO REAL SEAL; ROOT CANAL FILLING

Device Problem Insufficient Information (3190)

Patient Problem Missing Value Reason (3192)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Specific patient information with regards to age, gender, weight was not provided.The patients required a re-treatment of the root canal.The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.

Event Description

A doctor alleged that while performing a resilon retreatment several findings were noted.The findings were indicated as black pigmentation, soft resilon material, necrotic, and lesions.

• Brand Name: REAL SEAL
• Type of Device: 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: paulo calle ; 1717 w collins avenue; orange,
• MDR Report Key: 7384163
• MDR Text Key: 103917212
• Report Number: 2016150-2018-00015
• 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: Dentist
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2018
• 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