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	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after performing intraoperative spin and successful navigation checks, first screw was placed far lateral and outside the pedicle/vertebral body.The navigation appeared to be off 3-5mm left to right.The lateral screw was removed and replaced after performing a second spin.The case was completed using egps & e3d.
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.It was reported that an implant was misplaced during an intra-operative case.An investigation into the case logs revealed that the robot stayed on trajectory but the surveillance marker became hidden before going to the first screw (l2 left).The software correctly alerted the message on the ui and the sm tracker stayed grey during the l2 left trajectory.Because the sm was hidden, even if there was a drb shift, there would not have been indications that it did which could have led to the navigation appearing off.Additionally, based on the plan vs.Placed image of l2 left, it seems that the screw may have skived.These findings could contribute to the screw being lateral.Ultimately, the misplaced screw was replaced and corrected with no adverse effects to the patient 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.

• 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 ; +1(610)930-1800
• MDR Report Key: 50774352
• Report Number: 3004142400-2026-00193
• Device Sequence Number: 10614591
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K171651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Device Lot Number: GPS-0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Race: White