MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROBOTIC ARM CONTROL UNIT: GPS-0103

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Cerebrospinal Fluid Leakage (1772); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2020

Event Type  Injury  

Event Description

The patient had a planned single position lateral decubitus surgery for pedicle screw fixation and interbody fusion from l4-s1. Robotic guidance was planned for placement of pedicle screws from l4-s1 (6 screws) using the globus excelsius gps system. Two surgeons trained to use the globus excelsius gps system, two globus reps and a vascular surgeon were present during the procedure. The ict (intra-operative registration device (reference frame)) is placed in the iliac crest to assist with image merge. A dynamic reference base (drb (motion checker)) is also placed in the iliac crest and acts as surveillance marker for real-time intraoperative accuracy. The robotic software uses an algorithm to register intraoperative fluoroscopy scan images level by level (ap & lateral) and performs a 2d-3d merge with a pre-operative ct scan. This registration is intended to ensure that the radiographic images indicating the intended location of surgery and the actual patient position in the o. R. Matches, thus enabling the robot to guide screw placement. In this case, the software was having difficulty performing the initial image merge and registration. A software reset was advised by the rep. Following the system reset, they were able to complete image merge and registration. Once this was completed, registration scores were generated by the robot, which were reportedly adequate, indicating the images were matched. Palpation of landmarks was completed following registration and compared to the intraoperative images shown on the screen. However, palpation of landmarks as a secondary means of verifying system accuracy in the lateral position is more difficult. Following screw placement, an intra-operative ct scan showed sub-optimal positioning of 6/6 screws. The patient was then flipped onto a prone position for screw revision and replacement with decompression. One screw had penetrated the dura and a csf leak repair was performed. Post-operatively the patient has new foot drop with 0/5 dorsiflexion. The patient has an altered gait and will require rehabilitation services.

• Brand Name: EXCELSIUS GPS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead ave; valley forge business center; audubon PA 19403
• MDR Report Key: 10828567
• MDR Text Key: 215912539
• Report Number: 10828567
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROBOTIC ARM CONTROL UNIT: GPS-0103
• Device Catalogue Number: 5163-1001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/12/2020 Patient Sequence Number: 1