VDW GOLD/SILVER CONTRA ANGLE V041079000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for VDW GOLD/SILVER CONTRA ANGLE V041079000000 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[182764611] Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(6). The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[182764612] In this event it was reported that a contra angle 6:1 for vdw. Gold/silver would not hold files; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2020-00004
MDR Report Key9679864
Date Received2020-02-06
Date of Report2020-02-06
Date Mfgr Received2020-01-07
Date Added to Maude2020-02-06
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 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1W&H DENTALWERK BUERMOOS GMBH
Manufacturer Street53 IGNAZ-GLASER-STRASSE
Manufacturer CityBUERMOOS SALZBURG, 5111
Manufacturer CountryAU
Manufacturer Postal Code5111
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVDW GOLD/SILVER CONTRA ANGLE
Generic NameHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Product CodeEGS
Date Received2020-02-06
Model NumberNA
Catalog NumberV041079000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-06

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