CREO 5119.0542Recalls & reported problems
Globus Medical, Inc. · CREO Threaded 5.5 x 40mm Monoaxial Screw · Class 2
All models of CREO (100)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095099300), received between Apr 17, 2026 and Apr 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
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
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Migration
IT WAS REPORTED THAT REVISION SURGERY FOR SCOLIOSIS WAS PERFORMED DUE TO THE FACT THAT, ON X-RAY IMAGING, ONE OF THE LOCKING ELEMENTS (SET SCREWS) APPEARED TO BE LOOSENED. DURING THE PROCEDURE, IT WAS DISCOVERED THAT A SECOND LOCKING ELEMENT WAS ALSO LOOSE, ALTHOUGH THIS HAD NOT BEEN VISIBLE ON THE PREOPERATIVE X-RAY. THE SCREW WAS REPLACED WITH ONE OF A LARGER DIAMETER, AND THE SET SCREWS WERE REPLACED WITH NEW ONES. THE ISSUE CONCERNS THE USE OF COBALT-CHROMIUM RODS. AS OBSERVED IN THE ATTACHED IMAGE, WHEN A TITANIUM ROD IS USED, THE SET SCREW CAN BE TIGHTENED DEEPLY AND SITS FLUSH WITH THE SCREW HEAD (TULIP). HOWEVER, WHEN A COBALT-CHROMIUM ROD IS USED, THE SET SCREW CANNOT BE TIGHTENED FURTHER AND REMAINS SLIGHTLY PROTRUDING ABOVE THE LEVEL OF THE SCREW HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911448 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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.
How reports and recalls are matched · Editorial policy · Report an error on this page