MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BI70002000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 during a transforaminal lumbar interbody fusion (tlif) for l5 and s1, images were transferred from the imaging system and correctly set up on the mobile viewing station (mvs).While navigating the s1 vertebrae, they stated the s1 vertebrae appeared to have overlapping slices.They confirmed the rest of the image is clear.Spin was taken with the patient's arms kept at the side of the patient's body.In troubleshooting the rep recommended taking another spin if surgery allowed, opening the image annotation on the mobile viewing station (mvs) and adjusting the image's brightness/contrast and see if the image was able to be manipulated correctly.Patient was present.There was unknown surgical delay and impact on patient outcome.
Additional Manufacturer Narrative
H3, h6) the manufacture representative went to the site to test the imaging system and issue resolved same day with a re-spin by the representative.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): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20916062
• Report Number: 3006544299-2024-01034
• Device Sequence Number: 20778104
• Product Code: OWB
• UDI-Device Identifier: 00763000863302
• UDI-Public: 00763000863302
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/12/2024

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: 12/06/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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