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	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that screws using e3d needed to be revised and replaced.There was an intra-op ct using e3d.The previous hardware starts at l3 and goes up to thoracic spine.The surgeon was doing new hardware connecting to rod around l2 and l3, and new screws at l4, l5, s1, and s2ai.The screws on the left side were all accurate.The screws on the right side were all high into the disc space.Our screw cadence was right l4, left l4, right l5, left l5, etc.The screws appeared to go on well with minimal offset or deflection.We used reline open screws.High speed, pilot drill, screw were our steps.We needed to revise the right l4, right l5, right s1, and right s2ai robotically placed screws.
Additional Manufacturer Narrative
The device was not returned for evaluation.No determinations could be made as to the cause of the reported issue.

• 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: 50900589
• Report Number: 3004142400-2026-00204
• Device Sequence Number: 12271404
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Model Number: 6143.1001
• Device Lot Number: GPS-0136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• 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