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

Model Number	9735665
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that there was an alleged inaccuracy.During an oblique lumbar interbody fusion (olif) on l2-l3, they used the left side of the navigation system to take a navigated spin and the screw went into the canal on l2 which may have paralyzed the patient.When they took the screw out, the patient reportedly "almost jumped off the table." they switched to an open posterior procedure and re-spun using the right imaging system trackers and reported everything appeared to be accurate.This issue caused a 45-minute surgical delay.No additional information regarding the patient's outcome was reported.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735740, software version: 2.1.0 h3,h6: no products have been returned to medtronic for analysis.Codes b20, c20, and d15 are applicable.H6: code f24: insufficient health impact information is applicable to no additional information regarding the patient's outcome was reported.Code f1908: prolonged surgery is applicable to the 45-minute surgical delay.Code f1906: modified surgical procedure is applicable to they took the screw out, and they switched to an open posterior procedure.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 ; +1(763)526-5677
• MDR Report Key: 50550488
• Report Number: 1723170-2026-01257
• Device Sequence Number: 16046363
• Product Code: HAW
• UDI-Device Identifier: 00763000359881
• UDI-Public: (01)00763000359881(11)230331
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "See H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 220 LB