NAVLOCK 9734680

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 2020-03-24 for NAVLOCK 9734680 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[184648085] No patient information provided as no patient was involved in this concern. The navlock was returned to the manufacture for evaluation. After visual/physical examination the reported issue was confirmed. The returned probe has severe galling on the back end and impact marks causing the reported fit issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184648086] Medtronic received information regarding a navigation system. It was reported outside of a procedure that the site had two instruments that were not functioning properly prior to the case. They were not sliding smoothly when used in conjunction with the other items from the navlock tray and would often cause the pairing to get stuck together. There was no patient present at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01029
MDR Report Key9871625
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-05-30
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter 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 NameNAVLOCK
Generic NameORTHOPEDIC STEREOTAXIC INSTRUMENT
Product CodeOLO
Date Received2020-03-24
Returned To Mfg2020-03-16
Model Number9734680
Catalog Number9734680
Lot Number180530
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NAVIGATION, INC
Manufacturer Address826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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