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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC NAVLOCK TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736061
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Device manufacturing date, unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that during a revision case where they were adding l2 and l5 to an existing construct, there were issues tracking the blue and black navlocks and the robotic reference frame. They were tracking intermittently. The representative had the spheres replaced and verified they were snapped into place. There was no line of site issues. The representative moved or lights away as well. When the instrument was tracked it was showing up in the middle of the near/far tracking range under tracking details. The representative checked the geometry error and it was resting at. 35 -. 45 when the instrument was facing the camera straight on. No patient harm was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative reported that they did determine that the problem was not with the reference frame or any of the navlocks but rather was caused by interference from the surgeons camera headlight. When the surgeon stared at the surgeon tablet, they found that the instruments and reference frame would disappear from the tracking view, however, when he looked away, they would reappear. The problem only occurred when using that particular headlight. Since the issue was determined to not reside with the devices, they have not been returned for analysis.
 
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Brand NameNAVLOCK TRACKER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9700351
MDR Text Key183882609
Report Number1723170-2020-00481
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736061
Device Catalogue Number9736061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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