SMALL PASSIVE CRANIAL REFERENCE FRAME 961-337

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for SMALL PASSIVE CRANIAL REFERENCE FRAME 961-337 manufactured by Medtronic Navigation, Inc.

Event Text Entries

[186751422] Analysis of the returned reference frame found no fault. There was no apparent physical damage and none of the posts were bent. The reference frame returned good geometry, divot error, and normal tracking. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186751443] Medtronic received information regarding a navigation system that was used outside of procedure. The site had issues with tracking. The passive tracking spheres were changed without resolution. It was noted some of the posts on the instruments were bent, which threw off the geometry error. No patient present.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1723170-2020-01095
MDR Report Key9891859
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Device Manufacturer Date2011-12-16
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameSMALL PASSIVE CRANIAL REFERENCE FRAME
Generic NameINSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2020-03-27
Returned To Mfg2020-03-17
Model Number961-337
Catalog Number961-337
Lot Number111216
OperatorHEALTH PROFESSIONAL
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 2020-03-27

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