MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735667
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that the site was having accuracy issues in their spine procedures using the navigation system and imaging system.  there was no reported impact to patient outcome and a reported delay of less than one hour.
Additional Manufacturer Narrative
Continuation of d10: product id 9735670 (serial: (b)(6)).H3: no parts have been returned for analysis.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H2 additional information: medtronic was made aware of multiple occurrences of inaccuracies that occurred on this system.Medtronic was not made aware of these as they occurred, but after the fact.The following reports are related to this event: 1723170-2025-03043, 1723170-2025-03044, 1723170-2025-03045, and 1723170-2025-03146.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that the site has faced issue in multiple long segment spine fixation cases.Inaccuracy were faced in cases performed on (b)(6).All of these were cases where fixation was for more than 2/3 levels.There was approximately 5mm in inferior and superior directions; gross inaccuracy in medial and lateral directions.The clinical workflow for l1-l5/s1 procedures were as follows: the navigation system was position on the caudal end.There was adequate exposure of l1-s1 levels.Short clamp and stealthair reference frame on s1 spinous process.The clamp held the spinous process snuggly.They checked for serrations on the clamp and the appeared to be sharp enough to hold the spinous process.There was a low dose or standard 3d spin was taken with a patient in apnea.Immediately post the 3d spin, the surgeon started with screws.They used the orange and grey navlocks with awl sharp, thoracic probe, 4.5mm legacy cannulated tap followed by screws.They have observed the case with the same workflow.Immediately after the spin they asked the surgeon to check the accuracy at each level.They used all three instruments to check the accuracy.At l1-l2 levels there was an error of 2mm to 3mm.They put the instrument at spinous process, lamina, pedicle entry and the instrument was seen to be in air or at different location other than the anatomy.They have observed the farther they go from the reference frame the error was displayed in the navigation.L3-s1 accuracy showed perfect at the same t ime.They were having received complaints from the surgeon mentioning the same described issue in multiple cases of similar long segment fixations.
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3) the manufacturer representative went to the site to test the navigation system.The inaccuracy was observed during clinical case.Observed by changing the instruments, replaced ssd, reloaded software and done tracker calibration.Machine was working okay for 15 days.Again reported same issue, checked by placing demo machine and no issue observed on demo machine.Suspected issue with navigation camera and replaced camera.As it was intermittent issue and multiple parts were replaced.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735762, version #: 2.1.0 ; product id: 9735821, lot/serial #: unknown ; product id: 9736356, lot/serial #: unknown 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3, h6: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.Codes b01, c19, d15 are applicable to this analysis.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Common Device Name: NEUROLOGICAL 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 ; 7635265677
• MDR Report Key: 22982449
• Report Number: 1723170-2025-03149
• Device Sequence Number: 9709144
• Product Code: HAW
• UDI-Device Identifier: 00763000359782
• UDI-Public: (01)00763000359782(11)210309
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/21/2025

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: 9735667
• Device Catalogue Number: 9735667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 10/09/2025; 11/10/2025; 11/20/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/15/2025; 11/11/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown