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

Model Number 6143.1001

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that during a procedure using the excelsius gps system, a pedicle probe was placed and a medial breach with cerebrospinal fluid leak was observed and fixed intraoperatively.

Manufacturer Narrative

Investigation revealed there was no system malfunction.The imaging provided of the l2 preoperative merge revealed that the ap and lateral views contained shifts between the ct and fluoro images.Preoperative merges containing shifts can cause navigational integrity issues and can lead to the misplacement of screws.Additionally, review of the logs revealed that the user did not active the surveillance marker until they proceeded to the first trajectory (l2-r).Before proceeding with navigation, the user acknowledges that they will perform an anatomical landmark check to ensure navigational integrity.Additionally, the user acknowledges that the use of a surveillance marker can reduce registration shifts 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: 15845429
• MDR Text Key: 304132359
• Report Number: 3004142400-2022-00169
• 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: 11/16/2022

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-0166
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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