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 No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2016

Event Type  malfunction  

Event Description

A medtronic representative reported that when setting up for a lumbar fusion the instruments all verified and the set-up equipment page showed a green line between the non-medtronic c-arm and the stealth.The surgeon then made the incision and started the case.When they went back to acquire scans the c-arm became unresponsive and the screen was completely blank.This caused over an hour delay.The surgeon is inserting the cage on the patient but will need to reschedule the surgery for a later date to place screws.The c-arm was a siemens orbic system.They purchased the system about a year ago.The case has been rescheduled for tomorrow at 1pm so i am assuming they fixed the [c-arm] issue.The surgeon placed 2 cages in the patient but did not want to place the screws without navigation.(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: 17536359
• MDR Text Key: 321466096
• Report Number: MW5143247
• 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: 05/19/2016

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
• Patient Age: 47 YR