WAVEONE GOLD PRIMARY 6-FILE STER 31MM A0756231G0P03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-19 for WAVEONE GOLD PRIMARY 6-FILE STER 31MM A0756231G0P03 manufactured by Dentsply Maillefer.

Event Text Entries

[183568135] 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. 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


[183568136] In this event it was reported that a waveone broke during use. The separated piece could not be retrieved and was incorporated into the filling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00015
MDR Report Key9730923
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-19
Date of Report2020-03-02
Date Mfgr Received2020-01-20
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK, PA
Manufacturer CountryUS
Manufacturer Phone8494229
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWAVEONE GOLD PRIMARY 6-FILE STER 31MM
Generic NameFILE, PULP CANAL, ENDODONTIC
Product CodeEKS
Date Received2020-02-19
Returned To Mfg2020-02-11
Model NumberNA
Catalog NumberA0756231G0P03
Lot Number1384004
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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