EVEREST Spinal SystemRecalls & reported problems across all models
VB Spine LLC · 77 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one EVEREST Spinal System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 336
- Deaths reported
- 0
- Injuries reported
- 155
- Recalls
- 3
We found 77 models of EVEREST Spinal System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 336 adverse event reports in the FDA's MAUDE database, received between Sep 22, 2015 and Jul 28, 2026 — classified as 155 injuries, 179 malfunctions.
The most frequently reported specific device problem is “Fracture” (118 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVEREST Spinal System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 13, 2022Open, Classified
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Z-0706-2022 · Root cause: Process control · Recall details · FDA record ↗
- Jan 13, 2022Open, Classified
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Z-0705-2022 · Root cause: Process control · Recall details · FDA record ↗
- Nov 4, 2020Terminated
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
Z-0542-2021 · Root cause: Process change control · Recall details · FDA record ↗
Most reported EVEREST Spinal System problems
Device problems
- Fracture118
- Migration108
- Mechanical Jam34
- Migration or Expulsion of Device30
- Material Deformation26
- Adverse Event Without Identified Device or Use Problem8
- Deformation Due to Compressive Stress7
- Device Dislodged or Dislocated7
Patient problems
- No Clinical Signs, Symptoms or Conditions218
- No Information33
- Insufficient Information28
- No Consequences Or Impact To Patient27
- Pain27
- Injury23
- No Code Available4
- No Known Impact Or Consequence To Patient3
EVEREST Spinal System models
77 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVEREST® Spinal System 2901-10001APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- EVEREST Spinal System 5101-90195Orthopedic manual surgical instrument1 recall46 reports
- EVEREST Spinal System 5101-90167Orthopedic manual surgical instrument1 recall0 reports
- EVEREST Spinal System 5101-90168Orthopedic manual surgical instrument1 recall0 reports
- EVEREST Spinal System 2901-90098Orthopedic manual surgical instrument22 reports
- EVEREST Spinal System 5101-90129Orthopedic manual surgical instrument16 reports
- EVEREST® Spinal System 2911-07550APPLIANCE, FIXATION, SPINAL INTERLAMINAL7 reports
- EVEREST® Spinal System 2901-10001-SGOrthosis, spinal pedicle fixation, for degenerative disc disease6 reports
- EVEREST Spinal System 5101-90218Orthopedic manual surgical instrument6 reports
- EVEREST® Spinal System 2901-08590GORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- EVEREST Spinal System 2901-90033Orthopedic manual surgical instrument5 reports
- EVEREST® Spinal System 2911-06540ORTHOSIS, SPINAL PEDICLE FIXATION5 reports
- EVEREST Spinal System 5101-90219Orthopedic manual surgical instrument5 reports
- EVEREST® Spinal System 2911-07540APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- EVEREST Spinal System 5101-90012Orthopedic manual surgical instrument4 reports
- EVEREST Spinal System 2901-90110Orthopedic manual surgical instrument3 reports
- EVEREST® Spinal System 2911-35540ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- EVEREST Spinal System 5101-90107Orthopedic manual surgical instrument3 reports
- EVEREST Spinal System 5101-90160Orthopedic manual surgical instrument3 reports
- EVEREST® Spinal System 2901-08570GPedicle screw spinal system, adolescent idiopathic scoliosis2 reports
- EVEREST® Spinal System 2901-86055MFAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- EVEREST® Spinal System 2911-05530Orthosis, spondylolisthesis spinal fixation2 reports
- EVEREST® Spinal System 2911-06545Orthosis, spondylolisthesis spinal fixation2 reports
- EVEREST® Spinal System 2911-085110Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- EVEREST® Spinal System 2911-08540Orthosis, spondylolisthesis spinal fixation2 reports
- EVEREST® Spinal System 2911-095100Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- EVEREST® Spinal System 2911-35535APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- EVEREST® Spinal System F2911-06550APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- EVEREST® Spinal System M5111-05545ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- EVEREST® Spinal System M5111-08540ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- EVEREST® Spinal System M5111-08580ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- EVEREST® Spinal System M5111-08590ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- EVEREST® Spinal System E5111-05540ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- EVEREST® Spinal System E5111-05545Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- EVEREST® Spinal System E5111-06545Orthosis, spondylolisthesis spinal fixation2 reports
- EVEREST® Spinal System 101-85555EOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 101-85555FAPPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System 2901-07580GAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- EVEREST® Spinal System 2901-08580GOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 2901-75060Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 2901-75525GOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 2901-86055YAOrthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST Spinal System 2901-90034Orthopedic manual surgical instrument1 report
- EVEREST® Spinal System 2901-B60500Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST Spinal System 2901-N90006Orthopedic manual surgical instrument1 report
- EVEREST® Spinal System 2911-05545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System 2911-06550Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST® Spinal System 2911-07545Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 2911-07555APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System 2911-08545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System 2911-08555Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System 2911-08580Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST® Spinal System 2911-08585APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System 2911-08590Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- EVEREST Spinal System 5101-90014Orthopedic manual surgical instrument1 report
- EVEREST Spinal System 5101-90016Orthopedic manual surgical instrument1 report
- EVEREST® Spinal System F2911-05550ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System F2911-07540APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System M5111-05540ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System M5111-06540APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System E5111-06540Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST® Spinal System E5111-07540Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- EVEREST® Spinal System E5111-07545ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System E5111-07555Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- EVEREST® Spinal System E5111-08545APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- EVEREST® Spinal System E5111-01040APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- EVEREST® Spinal System F2911-06540-G1ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System E5112-06540Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- EVEREST® Spinal System E5112-06550APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- EVEREST® Spinal System E5112-07540Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST® Spinal System E5112-07545Orthosis, spondylolisthesis spinal fixation1 report
- EVEREST Spinal System 5101-90159Orthopedic manual surgical instrument1 report
- EVEREST Spinal System 5101-90161Orthopedic manual surgical instrument1 report
- EVEREST Spinal System 5101-90179Orthopedic manual surgical instrument1 report
- EVEREST® Spinal System M5111-06540-G1ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- EVEREST® Spinal System M5111-07555-G1Pedicle screw spinal system, adolescent idiopathic scoliosis1 report
- EVEREST® Spinal System SP-4201-02ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent EVEREST Spinal System adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJul 28, 2026Fracture
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 Screw fracture.
Patient problems: Pain
MAUDE report 50060267 ↗MalfunctionJun 29, 2026Fracture
IT WAS REPORTED THAT THE TIP OF AN EVEREST HEIGHT ADJUSTMENT CANNULATED DRIVER FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINS IMPLANTED IN THE SCREW HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661285 ↗MalfunctionJun 25, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN EVEREST CURVED THORACIC PROBE, HANDLE WITH IMPACTOR CAP FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630919 ↗MalfunctionMar 26, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN EVEREST CANNULATED HEIGHT ADJUSTMENT DRIVER FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703405 ↗MalfunctionMar 25, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WAS A 120 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24692553 ↗MalfunctionMar 8, 2026Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24542093 ↗InjuryFeb 24, 2026Device Dislodged or Dislocated
InjuryFeb 12, 2026Device Dislodged or Dislocated
THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 9 MONTHS.
Patient problems: Insufficient Information
MAUDE report 24326358 ↗InjuryFeb 12, 2026Device Dislodged or Dislocated
THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 9 MONTHS.
Patient problems: Insufficient Information
MAUDE report 24326347 ↗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 ↗MalfunctionJan 28, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN EVEREST MI XT POLYAXIAL SCREW WAS DIFFICULT TO REMOVE FROM THE PATIENT INTRA-OPERATIVELY AND THAT THE TULIP OF THE SCREW FRACTURED. THE SURGEON OPTED TO LEAVE THE FRACTURED SCREW IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 65-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201544 ↗
Other VB Spine LLC products
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- MESA Spinal System55 models · 140 reports
- ALEUTIAN Interbody Systems37 models · 135 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- PYRENEES Cervical Plate System29 models · 96 reports
- DENALI Spinal System22 models · 80 reports
- CASCADIA Interbody System28 models · 65 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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