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

Model Number SEQ MED RF 04 25 ASST

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Devices were not returned for evaluation as the dentist has not kept them.Dhrs were reviewed and no anomalies that may have possibly caused these breakages were found and further discussion with the dentist has not permitted to identify the root cause either.Such complaints will be tracked to follow their trend.

Event Description

In this event, it was reported that 2 files broke off (size 40 and 25), each involving a separate patient, reason for which this is the first of 2 reports for this event.In both cases, a file broke off in the patient's mouth and is still lodged in a canal of the treated tooth.

• Brand Name: ENDOSEQUENCE
• Type of Device: ENDODONTIC FILE
• Manufacturer (Section D): FKG DENTAIRE SA; crêt du locle 4; la chaux-de-fonds, CH-23 04; SZ CH-2304
• Manufacturer (Section G): FKG DENTAIRE SA; crêt du locle 4; la chaux-de-fonds, CH-23 04; SZ CH-2304
• Manufacturer Contact: romain baize ; crêt du locle 4; la chaux-de-fonds, CH-23-04 ; SZ CH-2304
• MDR Report Key: 6892970
• MDR Text Key: 89388878
• Report Number: 9680913-2017-00001
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: SEQ MED RF 04 25 ASST
• Device Catalogue Number: 5009013UO
• Device Lot Number: 34678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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
• Patient Age: 24 YR
• Patient Weight: 57