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	Use of Device Problem (1670); Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an imaging system being used during a procedure.It was reported that the system was unable to open when around a patient.Site reported that after 20 minutes, they were able to get the system open.No other additional information at the time of the call.This occurred intraoperatively, and there was less than one hour delay.There was unknown impact on patient involved.
Additional Manufacturer Narrative
(h3,h6) : manufacturing representative went to the site to test the system.They replaced tractor drive cover in accordance to service manual procedure.Verified no motion issues.Unit works as normal.Codes b01, c07, d02 are applicable.(h3,h6) : manufacturing representative went to the site to test the system.They reported issue on 12 oct 2025¿logs uploaded for further review.However, logs show the door open sequence was aborted because the door open button was released before the rotor could find its position.Tech could not recreate the issue.Unit works as intended.Codes b01, c19, d14 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m018081c001, serial/lot #:(b)(6), product id: bi71000142, serial/lot #: (b)(6), udi#: (b)(4); product id: bi71000143: 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 software investigation found that there is no software issue.Software was functioning as designed.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m018081c001, version: 4.3.0, mdr codes: b01, c19, 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.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 received "during completion of a posterior lumbar interbody fusion system failed to open.Emergency procedures were initiated too manually open the gantry.The patient was unconscious under anesthesia at the time.The patient was stuck on the surgery table until the gantry could be opened.This caused the patient to remain under anesthesia for an extra 20-30 mins before the gantry was open and the patient could safely be moved.Delay in care, excessive anesthesia.The gantry failed to dock despite multiple attempts and resets.The control panel was sluggish or did not respond to commands.We were not able to use it with any confidence.".
Additional Manufacturer Narrative
H2: additional information was added in patient details, a section.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
Correction: removed annex a code (a23).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: 23463894
• Report Number: 3004785967-2025-00703
• Device Sequence Number: 8945772
• Product Code: OWB
• UDI-Device Identifier: 00763000355555
• UDI-Public: (01)00763000355555(11)210710
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2026

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 11/09/2025; 12/12/2025; 04/23/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/05/2025; 12/30/2025; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 92 KG