EVEREST® Spinal System 2901-10001Recalls & reported problems
VB Spine LLC · 2901-10001 · Class 2 · Implant
All models of EVEREST Spinal System (77)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This VB Spine Everest spinal system has 119 adverse event reports, with 86 injuries and no deaths. Most describe implant parts migrating out of position after surgery. Reports rose from 5 in the prior 12 months to 13 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 119
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10888857037939), received between Oct 8, 2015 and Jul 28, 2026 — classified as 86 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Migration” (87 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.
Reports received per month
Most reported problems
Device problems
- Migration87
- Migration or Expulsion of Device26
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Device Slipped1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Information26
- Pain16
- Insufficient Information11
- Injury5
- No Code Available4
- No Consequences Or Impact To Patient3
- Fall1
Recent adverse event reports
The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Migration
A company representative reported that a patient was revised approximately 10 months post-operatively to address an Everest Set Screw migration and an Everest Cannulated Polyaxial Screw fracture. The patient reported experiencing pain.This report captures the Set Screw migration.
Patient problems: Pain
MAUDE report 50060275 ↗MalfunctionFeb 5, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST SCREW FRACTURED AND FOUR EVEREST SET SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE THIRD OF FOUR EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273360 ↗MalfunctionFeb 5, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST SCREW FRACTURED AND FOUR EVEREST SET SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE FOURTH OF FOUR EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273337 ↗MalfunctionFeb 5, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST SCREW FRACTURED AND FOUR EVEREST SET SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF FOUR EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273263 ↗MalfunctionFeb 5, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST SCREW FRACTURED AND FOUR EVEREST SET SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF FOUR EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273244 ↗InjuryJan 7, 2026Migration
InjuryJan 7, 2026Migration
InjuryDec 22, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23874177 ↗InjuryDec 22, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23874175 ↗InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE FOURTH OF FOUR SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23706758 ↗InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE THIRD OF FOUR SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23706755 ↗InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE FIRST OF FOUR SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23706620 ↗InjuryDec 3, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS FOUR MIGRATED EVEREST SET SCREWS AND TWO MIGRATED DENALI CONTOURED RODS. THIS REPORT CAPTURES THE SECOND OF FOUR SET SCREWS.
Patient problems: Insufficient Information
MAUDE report 23706602 ↗InjuryAug 28, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22919270 ↗InjuryAug 27, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909667 ↗InjuryJul 9, 2025Migration; Migration
InjuryJul 9, 2025Migration; Migration
InjuryDec 22, 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 SET SCREW.
Patient problems: Pain
MAUDE report 20997698 ↗InjurySep 10, 2024Migration; Migration
A PATIENT WAS REVISED TO ADDRESS MIGRATION OF TWO EVEREST ATR SET SCREWS AT L4 APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED EVEREST SET SCREWS AT L4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20183910 ↗MalfunctionJun 13, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT EXPERIENCED MIGRATION OF AN EVEREST ATR SET SCREW AT L4 APPROXIMATELY ONE MONTH AFTER IMPLANTATION. REVISION SURGERY IS NOT CURRENTLY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19534357 ↗MalfunctionJun 3, 2024Migration; Migration
A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED EVEREST SET SCREWS AT S1. DURING THE REVISION, THE SURGEON IDENTIFIED TWO ADDITIONAL MIGRATED EVEREST SET SCREWS AT L3. THIS REPORT CAPTURES THE FIRST OF TWO MIGRATED EVEREST SET SCREWS AT L3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19455475 ↗MalfunctionJun 3, 2024Migration; Migration
A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED EVEREST SET SCREWS AT S1. DURING THE REVISION, THE SURGEON IDENTIFIED TWO ADDITIONAL MIGRATED EVEREST SET SCREWS AT L3. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED EVEREST SET SCREWS AT L3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19455285 ↗MalfunctionMay 16, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT HAS EXPERIENCED POST-OPERATIVE MIGRATION OF AN EVEREST SET SCREW AT L3. REVISION SURGERY HAS NOT BEEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331914 ↗MalfunctionMay 16, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT HAS EXPERIENCED POST-OPERATIVE MIGRATION OF AN EVEREST SET SCREW AT L4. REVISION SURGERY HAS NOT BEEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331912 ↗MalfunctionMay 16, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT EXPERIENCED MIGRATION OF AN EVEREST SET SCREW AT L2 APPROXIMATELY TWENTY-SEVEN MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT CURRENTLY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331909 ↗
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- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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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