MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC LENTULO RA 21MM 2; INSTRUMENT, FILLING, PLASTIC, DENTAL

Catalog Number 671561

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.This report is for the first device.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.Multiple unsuccessful attempts were made to obtain the patient outcome.

Event Description

In this event it was reported two gates file lentulo ra 21mm 2 broke during initial use.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Involved products that broke during use were not returned and cannot be analyzed.Moreover, no unused gate is available for evaluation.Nothing unusual to report was found during dhrs review (batches #1283483 and #1324846).Root causes are not identified.We will track this kind of event and monitor the trend.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: LENTULO RA 21MM 2
• Type of Device: INSTRUMENT, FILLING, PLASTIC, DENTAL
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 9203253
• MDR Text Key: 191033083
• Report Number: 2320721-2019-00206
• Device Sequence Number: 1
• Product Code: EIY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 671561
• Device Lot Number: 1283483
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1