5.5/6.0 MAS NON-CANNULATED DRIVER 9735281

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 2020-03-19 for 5.5/6.0 MAS NON-CANNULATED DRIVER 9735281 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[184177235] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184177236] Medtronic received information regarding a navigation system being used outside of a procedure. There was no patient involvement. The screw driver instrument was reported to be defective. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-00972
MDR Report Key9856669
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MEDTRONIC NAVIGATION, INC
Manufacturer Street826 COAL CREEK CIRCLE
Manufacturer CityLOUISVILLE CO 80027
Manufacturer CountryUS
Manufacturer Postal Code80027
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.5/6.0 MAS NON-CANNULATED DRIVER
Generic NameORTHOPEDIC STEREOTAXIC INSTRUMENT
Product CodeOLO
Date Received2020-03-19
Model Number9735281
Catalog Number9735281
Lot Number170223
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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