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 01/03/2022

Event Type  malfunction  

Event Description

Mis tlif l4-5 was planned with non-globus implants (k2m), pre-op workflow.Drb was placed on left psis and surveillance marker was fixed on right psis.Everything was going smooth and fluoro merge was also good.Surgeon did not use high speed burr or drill and placed the screws in following sequence: 1.L4-r with mis awl+ kwire + mis screw.2.L5-r with same workflow.After placing l5-r screw, system gave warning "possible shift in drf" but accuracy was ok and we decided to proceed for left side screws.3.L4-l with same workflow.4.L5-l with mis awl + kwire (no screw).Fluoro shot was taken to verify the screws and found that l5-r was placed inferiorly while it was in the right position in planning.Other two screws and k-wire were placed perfectly as per the plan.After getting surveillance marker warning message left side screws were placed perfectly so it means drb position was not changed and the accuracy was good.Finally l5-r was repositioned by free hand.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Investigation revealed that there was no system malfunction.Engineering evaluations revealed that there was no system malfunction.Investigation of the case logs showed that the root cause is likely due to user technique; however, a definitive cause could not be determined due to the use of a competitive implant.The starting point of the l5-r screw was planned in a potential high-skive area.Additional pedicle preparation would have been needed to help place the screw due to the risk of skiving upon entrance.Additionally, during the bone work for l5-r, the software detected excessive forces on the load cell during bone work.This is the result of skiving forces detected while a tool is inserted in the end effector.Software correctly detected the warning and alerted the user.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: 18844236
• MDR Text Key: 337778372
• Report Number: 3004142400-2022-00191
• 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