MAUDE Adverse Event Report: Globus Medical, Inc. EXCELSIUS GPS; Robot, Surgical, navigation unit

Model Number	6143.1001
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Pain (1994); Spinal Column Injury (2081)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the initial surgery for an l1 fracture with fusion from t11 to l3 was performed in (b)(6) 2026.The inraoperative control x-rays were obtained and did not show any evidence of abnormal screw placement.Some time later, the patient underwent a second procedure consisting of an l1 corpectomy.The patient has now returned with pain, and a recent ct scan demonstrates that the screws at t11, t12, and l2 are laterally misplaced to the right side.
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.A warning was generated during navigation for the t11 right, l2 left, and l2 right screw trajectories.Navigation was continued despite the warnings, which contributed to inaccurate navigation and subsequent incorrect screw placement.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.

• Brand Name: EXCELSIUS GPS
• Common Device Name: Robot, Surgical, navigation unit
• 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 ; +1(610)930-1800
• MDR Report Key: 50086781
• Report Number: 3004142400-2026-00164
• Device Sequence Number: 13262426
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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-0603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 180 LB
• Patient Race: White