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	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a t10-l2 perc screw case with gps using pre-op workflow and registration.The merge was completed and determined to be successful.The l1 and l2 pedicle screws on the right were placed with no issues.After moving to t11, the md realized when he felt the drill hitting bone that the drill appeared on the screen as if the drill was halfway down the pedicle already.Because the robot was acting weird, we checked the screws under fluro and the t11 screw was proud and medial.All three screws were then removed.
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.It was reported that an implant was misplaced during a pre-operative case.An investigation into the case log revealed that the lateral image had very poor contrast where distinguishing the anatomy was very difficult.Because of this poor contrast, it seems that there was some shift in the registration that could have led to the misplaced implant.Ultimately, the misplaced implant was removed 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: 50736214
• Report Number: 3004142400-2026-00191
• Device Sequence Number: 10620214
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/11/2026

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-0155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: Unknown