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 foreign,health professional report with the FDA on 2019-11-24 for RAYPEX 6 APEX LOCATOR V041113000000 manufactured by Dentsply Vdw Gmbh.

Event Text Entries

[176833849] 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


[176833850] In this event it was reported that a raypex 6 apex locator gave incorrect measurements; no injury occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611053-2019-00415
MDR Report Key9367356
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-24
Date of Report2020-03-30
Date Mfgr Received2019-10-23
Date Added to Maude2019-11-24
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 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 Received2019-11-24
Model NumberNA
Catalog NumberV041113000000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY VDW GMBH
Manufacturer AddressBAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-24

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