EXCELSIUS GPS
Received Jul 21, 2026 · Event occurred Jun 16, 2026
Report 3004142400-2026-00146 · MDR key 25895128
Device
Generic name
Robot, Surgical, Navigation Unit
Manufacturer
Globus Medical, Inc.Model number
6143.1001Lot number
GPS-0253
Product problems
- Human-Device Interface Problem
Patient
Not reported
- Spinal Column Injury
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS UNAVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN EXCELSIUSGPS SURGERY, WE SPUN WITH E3D, SCAN LOOKED GREAT, WE PLACED ALL SCREWS, LOW OFFSET, GREEN DRB AND SURVEILLANCE, THEN WE TOOK X-RAYS POST-ROBOT AND LEFT T10/11 WERE MEDIAL INTO THE CANAL. WE REMOVED SCREWS AND THE SURGEON SAW CSF. WE RESPUN, AND REPLACED BOTH SCREWS. THE T11 WAS CORRECTED BUT T10 WENT EXACTLY WHERE IT WAS PREVIOUSLY, AGAIN ALL INDICATORS ON THE ROBOT WERE GREEN. WE REMOVED THE SCREW. THERE WAS ALSO A DURAL TEAR. THE PATIENT WAS DOING WELL THE NEXT DAY WITH NO DEFICITS.