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 Code	Insufficient Information (4580)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an excelsius gps surgery, the surgeon decided to abort a excelsius gps si lok surgery on (b)(6) 2026.He was not confident with the accuracy and safety checks.The entire surgery was aborted and the patient was already under anesthesia.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during an excelsius gps surgery, the surgeon decided to abort a excelsius gps si lok surgery on 18 feb 2026.He was not confident with the accuracy and safety checks.The entire surgery was aborted and the patient was already under anesthesia.
Additional Manufacturer Narrative
No case logs were submitted, so a formal investigation could not be performed.The user reported a loss of navigational integrity.The user acknowledges that they will perform an anatomical landmark check with each new instrument or level to ensure navigational integrity before proceeding with navigation.Ultimately, the case was completed with no adverse effects to the patient reported.This evaluation has been completed without associated case logs and there are no associated work order or part returns.The severity observed did not exceed the anticipated severity.The observed overall risk level is low, which does not exceed the observed anticipated risk level; therefore, the overall risk of the system has been maintained.The following sections were updated for this supplemental report: b4, g3, g6, h2, h3, h6, h10.

• 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 ; 6109301800
• MDR Report Key: 24653796
• Report Number: 3004142400-2026-00047
• Device Sequence Number: 17561999
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/15/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/15/2026
• 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