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  

Event Description

It was reported that screws using the excelsius gps system were misplaced intra-operatively and then removed.

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.The user reported that this patient had particularly hard bone and a steep angle of the sacrum, which can contribute to skiving.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.The overall anticipated risk level is low.The severity observed did not exceed the anticipated severity.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.

• 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: 19183243
• MDR Text Key: 341060461
• Report Number: 3004142400-2024-00071
• 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: 04/22/2024

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-0209
• 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
• Patient Sex: Female