WAVEONE GOLD PRIMARY 6-FILE STERILE 25MM A0756225G0P03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-11 for WAVEONE GOLD PRIMARY 6-FILE STERILE 25MM A0756225G0P03 manufactured by Dentsply Maillefer.

Event Text Entries

[183087913] 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. Returned waveone gold primary file 25mm is actually broken in the active part (fatigue). No material defect was found during analysis of the rupture pattern. No unused file is available for evaluation. Nothing unusual to report was found during dhr review (batch #1574008). Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10


[183087934] In this event it was reported that a waveone gold primary broke during use; the patient will be sent to specialist in endodontics to remove the broken part.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00030
MDR Report Key9820821
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-11
Date of Report2020-03-07
Date Added to Maude2020-03-11
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 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 STERILE 25MM
Generic NameFILE, PULP CANAL, ENDODONTIC
Product CodeEKS
Date Received2020-03-11
Returned To Mfg2020-02-10
Model NumberNA
Catalog NumberA0756225G0P03
Lot Number1574008
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2020-03-11

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