O-Arm O2 Imaging System

Description of Event or Problem

Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported that the accuracy of the imaging system was poor.Midway, a change was made to CT SPINE, and the operation was continued.This issue occurred intraoperatively and caused more than one-hour surgical delay. There was no reported impact on patient outcome.Additional information was received. It was reported that Vertical accuracy was good, but horizontal accuracy was poor.The number of scans taken: 2.The misalignment was approximately 3 mm inaccuracy.This was due to the need for repeat imaging, setup, and preparation of the CT SPINE.This event was not caused by the imaging system; it was caused by the navigation camera.

Additional Manufacturer Narrative

(H3,H6): No parts have been received by the manufacturer for evaluation. Codes B20, C20 <(>&<)> 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. 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.