MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. Stealth AXiS; Orthopedic Stereotaxic Instrument

Model Number	9736481
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure.It was reported that the trajectories could not be reached. all were marked as red.The site attempted to reposition to r-l5 and the trajectory guide ran into the patient reference frame clamped on l4.Surgeon grabbed the arm to stop it using the force sensor. performed anatomy checks with probe to confirm accuracy.Accuracy was confirmed and the procedure proceeded without re-registration. used the probe to manually send the arm to trajectories, as the original trajectories were still marked as unreachable.No known impact to patient outcome.There was a less than one hour surgical delay.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736551, serial/lot #: (b)(6), a manufacturer representative (rep) went to the site to test the navigation system.No hardware parts were replaced and the system performed as intended.Codes: b01, c19, and d14 h3) software analysis was performed and did not confirm the reported issue.The results of the analysis concluded that the system performance was consistent with current design specifications.All planned trajectories were positioned in close proximity to the patient reference frame.With the scanned safety volume, trajectories were correctly classified as unreachable due to safety volume collisions and solution-height constraints.After switching to a generic safety volume, a solution was generated for the r-l5 trajectory.During execution, the reported contact was more consistent with interaction between the robot and the reference frame clamp rather than the tracked reference frame itself, as clamp geometry was not modeled within the safety volumes and could have extended outside the protected region depending on clamp orientation.Navigation accuracy was subsequently verified using anatomical checks and remained within specification without requiring re-registration.Review found no evidence of a path planning, safety volume, or navigation accuracy malfunction.Codes: b01, c19, and d14 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Stealth AXiS
• Common Device Name: Orthopedic Stereotaxic Instrument
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50946488
• Report Number: 1723170-2026-01387
• Device Sequence Number: 18516425
• Product Code: OLO
• UDI-Device Identifier: 00763000984441
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 9736481
• Device Catalogue Number: 9736481
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 196 LB