EVEREST® Spinal System 2911-08540Recalls & reported problems
VB Spine LLC · 2911-08540 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857043039), received between Dec 20, 2024 and Sep 9, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Migration1
Patient problems
- Pain1
- Spinal Column Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE FRACTURED SCREW SHANK REMAINS IMPLANTED IN THE PATIENT AND THAT A NEW SCREW WAS INSERTED LATERAL TO THE FRACTURED SCREW. THE PROCEDURE WAS COMPLETED WITH A 15 MINUTE SURGICAL DELAY.
Patient problems: Spinal Column Injury
MAUDE report 23000009 ↗InjuryDec 20, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST-OPERATIVELY TO ADDRESS A MIGRATED EVEREST SET SCREW, DENALI ROD, AND EVEREST POLYAXIAL SCREW AT S1. THE PATIENT REPORTED EXPERIENCING SEVERE BACK PAIN. THIS REPORT CAPTURES THE EVEREST POLYAXIAL SCREW.
Patient problems: Pain
MAUDE report 20995698 ↗
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- 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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