MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Poor Quality Image (1408); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used during a sacroiliac and thoracolumbar procedure.It was reported that when using fov (field of view), they received an error that "can't be viewed with a rotated image, needed to set to 0.The representative rebooted and then able to use fov but images were black (unable to see screws or bone.) representative rebooted again and images "were better" but had artifact in them.They proceeded with the case using the scans.Patient was present.There was less than one hour of surgical delay and no impact on patient outcome.
Additional Manufacturer Narrative
H3, h6) the manufacture representative went to the site to test the imaging system and arrived onsite, unable to reproduce the field of view error message.It worked fine.They mentioned about one dark image and then second image look good.Performed 2d <(>&<)> 3d image quality checked using phantom.It passed.Performed system checkout successfully.System was working as per intended use.Handover the system for clinical use.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m021083c001.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: O-ARM O2 IMAGING SYSTEM
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (BOXBOROUGH); 200 beaver brook rd; boxborough,ma 45640 ; MX 45640
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (BOXBOROUGH); 200 beaver brook rd; boxborough,ma 45640 ; MX 45640
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22801845
• Report Number: 3004785967-2025-00554
• Device Sequence Number: 7798357
• Product Code: OWB
• UDI-Device Identifier: 00763000355555
• UDI-Public: (01)00763000355555(11)210206
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 76 KG