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

Model Number 6143.1001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Nervous System Injury (2689)

Event Date 11/08/2023

Event Type  Injury  

Event Description

It was reported that a screw using the excelsius gps system was misplaced intra-operatively causing a screw to breach the patient's spinal canal. .

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.Investigation revealed that there was no system malfunction.Investigation of the case logs revealed that the root cause is traced to user technique.Review of the patient registration for t10 showed that there is a preoperative merge shift.Preoperative merge shifts can cause navigational integrity issues can lead to the misplacement of screws.The t10 preoperative merge shift is caused by scan quality.Per the excelsius gps preoperative ct specifications, the scan should include 30 mm above and below the levels of interest.The t10 superior end plate is not within the scan field of view for this case, leading to increased merge difficulty.The user must verify the merge before proceeding with navigation.Additionally, the user acknowledges that they will perform an anatomical landmark check to ensure navigational integrity before proceeding with navigation.The cause of the reported issue was traced to user technique.

• Brand Name: EXCELSIUS
• 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: 18810365
• MDR Text Key: 336586694
• Report Number: 3004142400-2023-00196
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6143.1001
• Device Lot Number: GPS-0192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2023
• 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
• Patient Age: 31 YR
• Patient Sex: Male