MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC C FILE: 010 21MM LEXICON STERILIZED; FILE, PULP CANAL, ENDODONTIC

Catalog Number CFS01021

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Apicectomy (2372); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.This report is for the third device / patient.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a doctor broke three lexicon c-files in three separate patients.He was unable to retrieve the broken piece and an apicoectomy is planned in each case.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The lot number provided is invalid and we cannot perform a dhr review.

• Brand Name: C FILE: 010 21MM LEXICON STERILIZED
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7486769
• MDR Text Key: 107350828
• Report Number: 2320721-2018-00034
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CFS01021
• Device Lot Number: 3221210228166K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention