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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK UNIVERSAL GREEN TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK UNIVERSAL GREEN TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9734734
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
 
Event or Problem Description
Medtronic received information that, while outside of procedure, the green navlock tracker was not tracking accurately.There was no patient present at the time of the issue.
 
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Brand Name
NAVLOCK UNIVERSAL GREEN TRACKER
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7490254
Report Number1723170-2018-01920
Device Sequence Number19161104
Product Code OLO
UDI-Device Identifier00643169101968
UDI-Public00643169101968
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K124004
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Catalogue Number9734734
Device Lot Number170830
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2018
Initial Report FDA Received Date05/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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