RAYPEX 6 APEX LOCATOR V041113000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for RAYPEX 6 APEX LOCATOR V041113000000 manufactured by Dentsply Vdw Gmbh.

MAUDE Entry Details

Report Number9611053-2020-00064
MDR Report Key9827669
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-12
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 Phone8494424
Manufacturer G1FORUM ENGINEERING TECHNOLOGIES (96) LTD.
Manufacturer Street1 PLATIN STR. NEW INDUSTRIAL ZONE
Manufacturer CityRISHON LEZION HAMERKAZ, 7565339
Manufacturer CountryIS
Manufacturer Postal Code7565339
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAYPEX 6 APEX LOCATOR
Generic NameLOCATOR, ROOT APEX
Product CodeLQY
Date Received2020-03-12
Model NumberNA
Catalog NumberV041113000000
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 2020-03-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.