MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC.; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9736428
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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 trajectory 1 and 2 intermittently showed blank/black.The reference frame "jumped around" on tracking detail.The manufacturer representative (rep) confirmed that instruments not being used were out of view, that there were fingerprints on the right camera lens, that one sphere on the patient reference frame was red, and that the system was connected to a boom.The rep moved the camera in and out, pressed spheres down without using excessive force as the spheres were indirectly connected to the patient's spine, cleaned the camera lenses, and cleaned instruments.The issue did not replicate with another patient reference frame and no apparent issues were seen in the network device interface (ndi) toolbox.There was no surgical delay.There was no impact on patient outcome.
Additional Manufacturer Narrative
H6: the instrument (product #: 9736428) has not been returned to the manufacturer for evaluation.Codes b17, c20, and d15 are applicable.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.

• 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 ; 7635265677
• MDR Report Key: 24649775
• Report Number: 1723170-2026-00448
• Device Sequence Number: 9760728
• Product Code: OLO
• UDI-Device Identifier: 00763000554293
• UDI-Public: (01)00763000554293(11)230302(10)0011657563
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 03/20/2026

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: 9736428
• Device Catalogue Number: 9736428
• Device Lot Number: 0011657563
• 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: 03/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 64 KG