ROOT FILLER L V040393021035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for ROOT FILLER L V040393021035 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[103555228] 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.
Patient Sequence No: 1, Text Type: N, H10


[103555229] In this event it was reported that a paste filler separated; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


[119710795] Only unused paste fillers were returned. Involved product that broke during use is not available and cannot be analyzed. Nothing unusual to report was found during dhr 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9611053-2018-00029
MDR Report Key7366872
Date Received2018-03-23
Date of Report2018-05-22
Date Mfgr Received2018-05-07
Date Added to Maude2018-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY VDW GMBH
Manufacturer StreetBAYERWALDSTRASSE 15
Manufacturer CityMUNICH, 81737
Manufacturer CountryGM
Manufacturer Postal Code81737
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameROOT FILLER L
Generic NameINSTRUMENT, FILLING, PLASTIC, DENTAL
Product CodeEIY
Date Received2018-03-23
Returned To Mfg2018-02-23
Model NumberNA
Catalog NumberV040393021035
Lot Number179031
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-23

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