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 01/24/2022

Event Type  malfunction  

Event Description

During a posterior fixation following an xlif one of the two screws missed it's trajectory.The pedicles were extremely narrow.The plan showed an in-out-in trajectory and we think we went in, skived and didn't return back in.The surgeon quickly removed the screw and replaced it using traditional means utilizing the same entry point but sent the tip more medial with no issues.

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 revealed that the root cause is traced to user technique.The preoperative merge of l2 contains a rotational shift in both the ap and lateral.Merge shifts can cause navigation integrity issues and lead to the misplacement of screws.The user must verify the merge before proceeding to navigation.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: 18844242
• MDR Text Key: 337156615
• Report Number: 3004142400-2022-00194
• 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