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	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.It was reported that (3) si implants were misplaced superiorly during an intraoperative procedure.An investigation into the provided case logs revealed that the root cause was that the implants were placed with non-navigated instrumentation and k-wires, which moved during implant placement.Further discussion with a globus medical representative revealed that k-wires and other non-globus hardware were used in the procedure and that this system has only observed missed screws when non-globus hardware is being used.Notably, navigated globus instrumentation was only used to place the k-wire, which was then used to place the implants using non-globus, non-navigated instrumentation.Ultimately, the user did not opt to replace the misplaced implants, and no adverse effect to the patient was reported.The severity observed did not exceed the anticipated severity.The observed overall risk level is high or 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, there were some misplaced si-loc screws that were removed and replaced under fluoro.All 3 si r screw trajectories were posterior to plan.Dr.Navigated the hsb, 3.5 mm drill, and 6.5 mm drill, then used the cannulated tap to drop a k-wire and place a competitor's screws.We had green boarders and a low offset for each screw.

• 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: 25031864
• Report Number: 3004142400-2026-00080
• Device Sequence Number: 18707387
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/29/2026

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-0595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 04/29/2026
• 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