MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STRE SIEMENS ORBIC C-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Device Problem Image Orientation Incorrect (1305)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2016

Event Type  malfunction  

Event Description

A medtronic representative initially reported that during a case when using the c-arm siemens arcadis orbic with navigation for a l4-l5 spinal fusion the pa leaned on the reference frame.(b)(6) had surgeon check accuracy and the surgeon felt accurate.After the confirmation spin surgeon felt that the left l5 and the right l4 needed to be revised as they appeared to be in the disc space.After the revision, the screw placement felt accurate.Surgeon's workflow is to place a screw in the left l4 and l5 and then the right l4 and l5.There was no patient impact.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIEMENS ORBIC C-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STRE
• MDR Report Key: 17528954
• MDR Text Key: 321412617
• Report Number: MW5135883
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2016

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1