MAUDE Adverse Event Report: DENTSPLY VDW GMBH ROOT FILLER -L-, STERILE; INSTRUMENT, FILLING, PLASTIC, DENTAL

Catalog Number V040393025030

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report with the same product where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that paste fillers of a certain lot are separating.No injury reported.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

The involved paste fillers that have broken during use have not been returned and cannot be analyzed.Nothing unusual to report was found during dhrs review (batches #1455636, #1478554 and #1477871).The unused paste fillers 25mm n°2 returned have been measured and have been found in compliance with specifications.For information, no mechanical test is applicable regarding this product.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: ROOT FILLER -L-, STERILE
• Type of Device: INSTRUMENT, FILLING, PLASTIC, DENTAL
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 10916508
• MDR Text Key: 219374367
• Report Number: 9611053-2020-00367
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040393025030
• Device Lot Number: 264710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 01/30/2021
• Patient Sequence Number: 1