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

Model Number	6143.1001
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.The case was completed with no adverse effects to the patient reported.The complaint description states that there was constant drb movement the reset as a result.The user is always advised to verify navigation integrity by performing a landmark check, and the description also stated that the user went ahead with the procedure even though the landmark check failed.The severity observed did not exceed the anticipated severity.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.The cause of the reported issue can be traced to user technique.
Event or Problem Description
During a case we placed a sp clamp on s1 to instrument l5-s1 with freehand navigation.During the case, at several times, the drb had shifted due to over-mobility of the body- we were alerted from what we visually saw, as well as the sm going red.We performed landmark checks the first two times, and sm was reset accordingly.After a third time, the landmark check was off without a doubt.After screws were placed (right side only), he believed that l5 was placed lateral to plan, as well as s1.

• Brand Name: EXCELSIUS GPS
• Common Device Name: 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: 25137132
• Report Number: 3004142400-2026-00096
• Device Sequence Number: 18505212
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: 6143.1001
• Device Lot Number: GPS-0589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown