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 02/12/2024

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 "misplaced tools or implants" for excelsiusgps.Investigation of the case logs showed that the root cause of the misplaced implants is due to a combination of skiving, patient movement relative to the drb and tracking errors in the fluoroscopic images.For skiving, the user reported that they skived due to small and sclerotic pedicles.Additionally, investigation of the case logs showed that 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 into the end effector.The software correctly detected this force and alerted the user.Misplaced screws due to skiving is being further investigated in relationship to capa-23-0052.For patient movement relative to drb, it was reported that the surgeon continued to dissect and incise further following patient registration.This can lead to movement of the patient's anatomy relative to the drb, resulting in misplaced implants.Furthermore, review of the fluoroscopic images revealed that assigned images contained tracking errors.A tracking error can occur if the c-arm moves with respect to the patient between x-ray emission and when the image is received by the excelsiusgps software.Tracking errors can lead to preoperative merge shifts and navigational integrity issues.The cause of the reported issue was traced to user technique.

Event Description

It was reported that a screw using the excelsius gps system was misplaced intra-operatively causing a csf (cerebral spinal fluid) leak.

• 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: 18888339
• MDR Text Key: 337472370
• Report Number: 3004142400-2024-00048
• 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: 03/12/2024

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-0208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/12/2024
• 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