EVEREST® Spinal System 2911-05530Recalls & reported problems
VB Spine LLC · Polyaxial Screw Size Ø5.5x30 mm · Class 2 · Implant
All models of EVEREST Spinal System (77)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857041851), received between Jul 29, 2022 and Jul 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO (2) DEFORMED EVEREST POLYAXIAL SCREWS WERE LEFT IN A PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136267 ↗MalfunctionJul 29, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO (2) DEFORMED EVEREST POLYAXIAL SCREWS WERE LEFT IN A PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15136214 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- 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.
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