MAUDE Adverse Event Report: GLOBUS MEDICAL INC. GLOBUS MEDICAL EXCELSIUS E3D; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  Injury  

Event Description

The patient was scheduled for a lumbar fusion with spinal instrumentation using computer navigation and robotic assistance using the globus medical excelsius 3d imaging system.I had been notified by the globus representative on the morning of surgery that there was a potential problem with the battery supply of the globus imaging system but that it had been addressed by the engineers and there should be no problem.I was told that even if there was a battery issue the system could run from electrical power from the wall.Once the patient was asleep and the exposure to the spine was complete, the globus imaging system was brought in for obtaining the images.It immediately shut down and could not be restarted.As a result i was unable to proceed with the computer navigation or robotic assistance that i had explained to the patient.My options were to either cancel the surgery and close the wound to return another day once the system was working or proceed without the navigation and robotic assistance.I choose to proceed with the surgery using the traditional approach without navigation or robotics.Fortunately the surgery went well without complications.I was able to continue with surgery as i had been trained and in practice prior to the widespread use of computer navigation and robotic systems in spine surgery.If i had been a more recent graduate i would not likely have had this ability and the surgery would have had to be aborted.This is at least the third issue our hospital has had with battery failure using this globus system in the last year.Following this episode i had a phone meeting with the globus medical senior vp in charge of the navigation and robot system, (b)(6) and others from his team.During this conversation i asked if this battery issue was unique to our device or if it was a system wide problem.He confirmed that it was a system wide problem.He stated they are currently working on new battery options that are currently under review by the fda and hope to be available in the next month or so.His solution for us was to provide an additional imaging system to be used as a backup in case of future battery failures.I was never made aware of this ongoing, system wide issue with battery failure by globus medical either during their surgeon training program or at any time as a user of their device.If they knew this failure was happening, they should make aware to all surgeons using this product so they can make educated decisions on whether to use it or at minimum to verify a backup plan in case of battery failure during a surgery.I also spoke with the globus lead engineer for this system, (b)(6), who confirmed the ongoing issue with battery failures and their current work on a new battery system.He also explained that the current system is completely dependent on the battery functioning as it is unable to run off wall electrical power.This is not what i was told by the other representative the morning prior to the battery failure.Reference reports mw5151748, mw5151749.

• Brand Name: GLOBUS MEDICAL EXCELSIUS E3D
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GLOBUS MEDICAL INC.; audubon PA 19403
• MDR Report Key: 18737983
• MDR Text Key: 335866790
• Report Number: MW5151747
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention