EXCELSIUS3D

Description of Event or Problem

It was reported that E3D intraop scan showed a slight double image on the initial scan. the first screw was still attempted to be placed with egps but showed lateral in an x-ray. egps did a bailout and respun with e3d but had worse artifact and no further imaging was attempted. The first screw was placed laterally and was removed after xray imaging. The procedure was not completed and was staged with a preoperative CT workflow for the following day.

Additional Manufacturer Narrative

Investigation revealed that there was no system malfunction. Excelsius3D and ExcelsiusGPS were utilized during an L4-L5 ALIF procedure on (b)(6) 2026, using the intraoperative workflow. It was reported to Globus Medical that, following an intraoperative spin with Excelsius3D, the user observed that the CT scan appeared as a double image when transferred to ExcelsiusGPS. The surgeon proceeded with the procedure and attempted screw placement. During insertion, it was determined that the first screw had been placed laterally and it was subsequently removed. The surgeon then elected to utilize the bail-out option and acquire another navigated CT scan; however, the repeat scan again displayed a double image. The procedure was subsequently aborted, and a revision surgery utilizing the preoperative CT workflow was scheduled for the following day. When using ExcelsiusGPS with the intra-op workflow, it is recommended that once "registration has been completed, perform a landmark check or verification to ensure that the registration was successfully calculated". Additionally, the Excelsius3D user manual states that "any patient movement during the rotation of the X-ray source degrades the quality of the resulting image. Whenever possible, all patient motion should be inhibited during 3D image acquisition". The reported observation of a double image is consistent with image degradation that may occur when motion is present during image acquisition. Testing verified that the system met established functionality and image quality requirements, and no device malfunction was identified. Based on the available evidence, a device-related cause could not be confirmed. Post-event functionality and image quality testing verified that the system performed as intended and the reported condition could not be reproduced. Potential contributing factors include inadequate registration verification and/or patient motion during image acquisition, both of which are addressed in the product labeling. The severity observed did not exceed the anticipated severity. The observed risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required. The cause of the reported issue can be traced to user technique.