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.Any applicable parts will be returning to the methuen imaging, navigation & robotics (inr) site and processed per wi-bs-0031 nonconformance work instruction.An investigation into the case logs revealed the root cause was excessive deflection forces, or skiving during navigation.The software correctly detected and alerted the user of high deflection forces present on the load cell during bone work.This excessive force present on the load cell is likely the result of instrument skiving that was detected while a tool was inserted into the end effector.Ultimately, the user opted to replace the misplaced implant using another navigation system with no adverse effects to the patient reported.This evaluation has been completed, and there are no associated work orders 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, an l1-l3 fusion occurred at an account that has reported previous problems with the robot missing screws.Fse came out last week and found that the camera was out of spec.Custom perc in was placed in psis, and drb and sm were attached to the same post.The workflow was high-speed burr, straight pedicle probe tap, and driver.Navigation showed perfect placement of screw-down pedicle.When moving to the right l1 trajectory, the surgeon reported that the tactile feel with the pedicle probe didn't feel right and wanted to do another spin with e3d.Upon taking our first ap scout shot to prepare for spin, we saw that the first screw at left l1 was completely lateral to the pedicle.A new spin with e3d was done, and we could see the trajectory of the right l1 screw that we were working on was lateral and superior with o-arm and medtronic stealth.In the previous cases, where missed screws were reported, the robot placed screws very similarly to how we observed in this case.No drb shifts were observed by the robot or the surgical team.

• 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: 25057896
• Report Number: 3004142400-2026-00083
• Device Sequence Number: 13086507
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/01/2026

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-0585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 05/01/2026
• 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