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

Model Number 6143.1001

Device Problem Human-Device Interface Problem (2949)

Patient Problem Spinal Column Injury (2081)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Investigation revealed that there was no system malfunction.The purpose of this investigation is to evaluate the risk associated with the identified failure mode of navigational integrity.Investigation of the case logs showed that the misplacement of implants is due to a combination of the patient registration containing a pre-operative merge shift and a potential drb shift.The preoperative merge can be more difficult depending on the quality of the preoperative ct scan, quality of the fluoroscopic images and patient anatomy.Preoperative merge shifts can cause navigational integrity and can lead to the misplacement of implants.The user must verify the preoperative merge before proceeding with navigation.Additionally, the software alerted the user of a possible shift of the drb during navigation.The user repaired the drb to the surveillance marker and proceeded with navigation.The user acknowledges that they will perform an anatomical landmark check with each new instrument or level to ensure navigational integrity before proceeding with navigation.The observed overall risk level is low.The overall risk of the system has been maintained and there is no further investigation required.The cause of the reported issue was traced to user technique.

Event Description

It was reported that screws using the excelsius gps system were misplaced intra-operatively and then removed and replaced, with subsequent dural tear that was repaired.

• 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: 19183242
• MDR Text Key: 341060452
• Report Number: 3004142400-2024-00073
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-0413
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/25/2024
• 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