MAUDE Adverse Event Report: Globus Medical, Inc. EXCELSIUS HUB; Robot, Surgical, navigation unit

Model Number	6203.1001
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the surgeon just had to respin because the spin wasn't accurate.Checked his c7 screws and they were incorrect north/south (lower than they were planned) his c2 screws were thankfully correct.We respun and it seems to be accurate again.
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 and comparing the placed vs.Planned images, the c7 screw shows rotation around a point, indicating a potential shift of the registration and leading the screws to be misplaced more caudally.Ultimately, misplaced implants were replaced 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 HUB
• 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: 50774359
• Report Number: 3004142400-2026-00196
• Device Sequence Number: 21486473
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 6203.1001
• Device Lot Number: HUB-0101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• 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: Male