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

Catalog Number V040393021030

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

In this event it was reported that a paste filler separated.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The paste filler returned in loose is actually broken at the base of the active part.No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhrs review.Unused instruments were measured and were 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.Additional information was received indicating that the broken piece was easily retrieved and no injury resulted.

• Brand Name: ROOT FILLER L
• Type of Device: INSTRUMENT, FILLING, PLASTIC, DENTAL
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• 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: 7366874
• MDR Text Key: 103553082
• Report Number: 9611053-2018-00030
• Device Sequence Number: 1
• Product Code: EIY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040393021030
• Device Lot Number: 103253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1