MAUDE Adverse Event Report: FKG DENTAIRE SA ENDOSEQUENCE FILE; ENDODONTIC FILE

Model Number SEC LRG RF 04 25 ASST 4P

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

A #25 endoseqhence file separate in the canal of tooth #19.The pt was sent to an endodontist to complete the root canal therapy.The endodontist was able to remove the top half of the file, but not the rest.The endodontist was able to seal up the apex and complete the root canal.The remainder of the file was left in the tooth.

• Brand Name: ENDOSEQUENCE FILE
• Type of Device: ENDODONTIC FILE
• Manufacturer (Section D): FKG DENTAIRE SA; rue du cent 7; la chaux-de-fonds, la chaux-de-fonds CH23 00; SZ CH2300
• MDR Report Key: 4847594
• MDR Text Key: 5937256
• Report Number: 1032227-2015-00013
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SEC LRG RF 04 25 ASST 4P
• Device Catalogue Number: 5014383U0
• Device Lot Number: 23041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2015
• Distributor Facility Aware Date: 05/21/2015
• Event Location: Other
• Date Report to Manufacturer: 06/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 122