MAUDE Adverse Event Report: SYBRONENDO TF ADAPTIVE MEDIUM/LARGE; FILE

Catalog Number 817-4003

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

Specific information with regard to the patient's gender, age, and weight was not provided.The doctor called to report the breakage of the file in the patients mouth.Due to the breakage of the file, the patients tooth was extracted however no medical intervention was required.The returned device was evaluated yielding passing specifications.

Event Description

An alleged complaint was reported that a file broke in the patient's canal resulting in the doctor extracting the patient's tooth.

• Brand Name: TF ADAPTIVE MEDIUM/LARGE
• Type of Device: FILE
• Manufacturer (Section D): SYBRONENDO; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): SYBRONENDO; 1332 south lone hill avenue; glendora 91740
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, CA 92867 ; 7145167752
• MDR Report Key: 6752309
• MDR Text Key: 81362384
• Report Number: 2016150-2017-00002
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 817-4003
• Device Lot Number: 051780942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other