MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS; SYSTEM, EXCELSIUS GPS, 120V

Model Number 999.893

Device Problem Human-Device Interface Problem (2949)

Patient Problem Spinal Column Injury (2081)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

Merge was more challenging than expected.Took 60 fluoro shots for l2-s1.We placed our first screw, clicked on the next screw, pressed the foot pedal, and the arm lifted about halfway up the creo mis tulip then started to translate over while tulip was still partly in the ee.We placed the next screw, and it did the same thing, back halfway off then translate to new trajectory while still around the tulip.We got an error message that said "arm cannot fully back out of trajectory" and this happened a few more times even though our borders were all green.Final incident was we placed a screw, hit a new trajectory, and the robot arm pressed farther into the patient.No error message.We backed the robot away from the table a little and we didn't run into another issue.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Investigation revealed that there was no system malfunction.-for the difficult merge, engineering evaluations revealed that there was no system malfunction.Investigation of the case logs revealed that the root cause is traced to a non-device related factor.The merge can be more difficult depending on the quality of the preoperative ct, the quality of the fluoroscopic images and the patient's anatomy.The user was able to obtain a successful merge before proceeding to navigation.For the motion issues, engineering evaluations revealed that there was no system malfunction.Investigation of the case logs revealed that the software appropriately alerted the user to multiple motion related warnings during navigation.The first warning was "the robotic arm is unable to fully back of trajectory".This warning means that the system cannot find a solution to put the end effector in the desired position.The user is instructed to either allow movement or manually move the arm.The next warning is "motion obstructed" which occurs if a significant force is detected on the load cell.The user is instructed to make sure there are no obstructions.The final warning was "arm reachability conflict", which instructs the user to move the end effector to a new starting position and restart trajectory guidance.All these warnings are expected per system design.All motion is visible by the user.The ability to stop motion at any time can be achieved by the existing mitigations of the dead man switch.The user can either disengage the surgeon bracelet/foot pedal or engage the emergency stop button.The case was successfully completed without any adverse effect to the patient.The cause of the reported issue was traced to user technique.

• Brand Name: EXCELSIUS GPS
• Type of Device: SYSTEM, EXCELSIUS GPS, 120V
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18844239
• MDR Text Key: 337434041
• Report Number: 3004142400-2022-00192
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Device Model Number: 999.893
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other