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	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.An investigation into the case logs provided revealed that a registration shift was the cause of the misplaced implant.Registration shifts can cause a loss of navigational integrity and can lead to the misplacement of implants.The user must verify the intra-operative registration before proceeding with navigation.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 user opted to re-register and replace the misplaced implant intraoperatively with navigation 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 at an excelsius gps surgery, we had a misplaced screw.It was e3d intra-op, mis, creo mis implants.There was a kyphoplasty done before the spin at l1.Then the screws planned for t12 and l2.There was a spin done after kyphoplasty.The screws planned with the surgeon and the end effector brought in.We went: high speed burr, pilot drill, tap, screw.The first screw did not give us a green check mark.The surgeon decided to check the screw via fluoro and found that it was placed outside of the pedicle.The screw was removed and replaced in an appropriate position in pedicle after a second spin.The neuromonitoring did not detect any rise in numbers from the screw.The patient was said to be in standard recovery from surgery.A re-spin was done and all four screws were placed accurately and confirmed via fluoro.

• 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: 24765412
• Report Number: 3004142400-2026-00058
• Device Sequence Number: 18717014
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/02/2026

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-0363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 04/02/2026
• 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