EXCELSIUS GPS 6143.2692Recalls & reported problems
Globus Medical, Inc. · CREO MIS Driver Outer Sleeve, 30mm, GPS · Class 2
All models of EXCELSIUS GPS (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193982278724), received between Oct 15, 2025 and Oct 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K171651); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Human-Device Interface Problem1
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING A CASE USING THE 30 MM MIS GPS DRIVER AND WHILE PUTTING IN SCREWS THE SURGEON FIGURED OUT THAT ON THE NEW 2 PIECE STYLE GPS DRIVERS, THEY CAN SLIDE DOWN THE ARRAY WITHOUT KNOWING ON NAVIGATION. THEY ENDED UP PUTTING IN A SCREW FURTHER THAN WE KNEW ON THE SCREEN AND DIDN'T CATCH IT TILL A CONFIRMATION SPIN OF THE SCREWS. THEY ALSO MEASURED THIS AFTER THE CASE AND THE DRIVER CAN SLIDE 8 MM FURTHER DOWN THE TUBE IF YOU ACCIDENTALLY HIT THE BUTTON IN THE MIDDLE OF THE ARRAY.
Patient problems: Spinal Column Injury
MAUDE report 23294891 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171651. One submission often covers many models, so check the product and lot details in each record.
- Z-1007-2024 · Dec 15, 2023 · Open, ClassifiedExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
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- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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