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	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.It was reported that an implant at l3 was misplaced laterally during an intra-operative procedure.An investigation into the case revealed that the root cause was that the intra-operative ct was acquired with an out-of-calibration e3d system.After a site visit by a globus medical field service representative, further discussions revealed that the e3d was out of calibration.This can lead to registration shifts and navigational accuracy issues when placing implants.Ultimately, the user opted to remove the misplaced implant, and no adverse effect to the patient was reported.This evaluation has been completed via 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 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
It was reported that while using the excelsius gps system, all screws were lateral, despite l3 obviously being lateral.We are now leaving that screw out and hoping for unilateral fusion at that level.

• 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: 25094093
• Report Number: 3004142400-2026-00093
• Device Sequence Number: 15950113
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/06/2026

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-0135P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/06/2026
• 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