OZARK Cervical Plate SystemRecalls & reported problems across all models
VB Spine LLC · 54 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 270
- Deaths reported
- 0
- Injuries reported
- 92
- Recalls
- 0
We found 54 models of OZARK Cervical Plate System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2020 and Sep 17, 2026 — classified as 92 injuries, 178 malfunctions.
The most frequently reported specific device problem is “Fracture” (196 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. 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
Most reported OZARK Cervical Plate System problems
Device problems
- Fracture196
- Migration59
- Material Deformation26
- Detachment of Device or Device Component19
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated5
- Material Separation5
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions221
- Pain22
- No Consequences Or Impact To Patient19
- Neck Pain16
- Insufficient Information11
- Injury6
- Dysphagia/ Odynophagia2
OZARK Cervical Plate System models
54 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OZARK Cervical Plate System 8801-04016DAAppliance, fixation, spinal intervertebral body44 reports
- OZARK Cervical Plate System 8801-04014DAAppliance, fixation, spinal intervertebral body40 reports
- OZARK Cervical Plate System 8801-90034Orthopedic manual surgical instrument37 reports
- OZARK Cervical Plate System 8801-04016CAAppliance, fixation, spinal intervertebral body20 reports
- OZARK Cervical Plate System 8801-04018DAAppliance, fixation, spinal intervertebral body14 reports
- OZARK Cervical Plate System AA01-42F38VAppliance, fixation, spinal intervertebral body8 reports
- OZARK Cervical Plate System 8801-04014CAAppliance, fixation, spinal intervertebral body6 reports
- OZARK Cervical Plate System 8801-04018CAAppliance, fixation, spinal intervertebral body6 reports
- OZARK Cervical Plate System AA01-42F40VAppliance, fixation, spinal intervertebral body6 reports
- OZARK Cervical Plate System 8801-04012CAAppliance, fixation, spinal intervertebral body5 reports
- OZARK Cervical Plate System 8801-04514DAAppliance, fixation, spinal intervertebral body5 reports
- OZARK Cervical Plate System 8801-14016CAAppliance, fixation, spinal intervertebral body4 reports
- OZARK Cervical Plate System 8801-14016DAAppliance, fixation, spinal intervertebral body4 reports
- OZARK Cervical Plate System 8801-04020CAAppliance, fixation, spinal intervertebral body4 reports
- OZARK Cervical Plate System 8801-90074Orthopedic manual surgical instrument4 reports
- OZARK Cervical Plate System 8801-04016DA-G1Appliance, fixation, spinal intervertebral body4 reports
- OZARK Cervical Plate System 8801-14018DAAppliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System 8801-14020DAAppliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System AA01-42F42VAppliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System AA01-43F57VAppliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System AA01-43F60VAppliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System 8801-04014DA-G1Appliance, fixation, spinal intervertebral body3 reports
- OZARK Cervical Plate System 8801-14018CAAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System 8801-14316DAAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System 8801-04318DAAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System 8801-04516DAAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System AA01-41F18VAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System AA01-43F51VAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System AA01-43F54VAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System AA01-43F63VAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System AA01-45F100VAppliance, fixation, spinal intervertebral body2 reports
- OZARK Cervical Plate System 2601-90008ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- OZARK Cervical Plate System 8801-43F57Appliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-90006Orthopedic manual surgical instrument1 report
- OZARK Cervical Plate System 8801-14012DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-14014DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-14318DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-14514DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-04512CAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-04020DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System 8801-04316DAAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-41F16VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-41F20VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-41F24VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-41F36VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-42F34VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-42F36VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-42F44VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-43F66VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-44F65VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-44F69VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-44F79VAppliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System AA01-42F40V-G1Appliance, fixation, spinal intervertebral body1 report
- OZARK Cervical Plate System SP-4212ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent OZARK Cervical Plate System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50809846 ↗InjurySep 17, 2026Migration
A company representative reported that a patient was revised approximately three months post-operatively to address a fractured and migrated Ozark 2 Level Plate locking cover and four migrated Ozark Self-Tapping Variable Screws. This report captures the third of four Screws.
Patient problems: Insufficient Information
MAUDE report 50809839 ↗InjurySep 17, 2026Migration
A company representative reported that a patient was revised approximately three months post-operatively to address a fractured and migrated Ozark 2 Level Plate locking cover and four migrated Ozark Self-Tapping Variable Screws. This report captures the second of four Screws.
Patient problems: Insufficient Information
MAUDE report 50809827 ↗InjurySep 17, 2026Fracture; Migration
A company representative reported that a patient was revised approximately three months post-operatively to address a fractured and migrated Ozark 2 Level Plate locking cover and four migrated Ozark Self-Tapping Variable Screws. This report captures the Plate.
Patient problems: Insufficient Information
MAUDE report 50809816 ↗InjurySep 17, 2026Migration
Patient problems: Insufficient Information
MAUDE report 50809815 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781041 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780962 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780960 ↗MalfunctionMar 5, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING COVERS ON AN OZARK 1 LEVEL PLATE FRACTURED AND MIGRATED APPROXIMATELY 13 MONTHS POST-OPERATIVELY. UPON REVIEW OF X-RAY IMAGING PROVIDED, IT WAS OBSERVED THAT AN OZARK SCREW ALSO FRACTURED. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FRACTURED SCREW.
Patient problems: Insufficient Information
MAUDE report 24520317 ↗InjuryMar 3, 2026Fracture; Migration
MalfunctionFeb 26, 2026Fracture; Migration
A COMPANY REPRESENTATIVE REPORTED THAT AN OZARK 1 LEVEL PLATE FRACTURED APPROXIMATELY 13 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 24454235 ↗MalfunctionJan 21, 2026Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136020 ↗InjuryJan 21, 2026Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136018 ↗InjuryJan 21, 2026Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136016 ↗MalfunctionNov 25, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN OZARK SELF-STARTING VARIABLE SCREW FRACTURED POST-OPERATIVELY. THE FRACTURED SCREW WAS OBSERVED IN A PLANNED REVISION SURGERY FOR ADJACENT LEVEL DISEASE APPROXIMATELY ONE YEAR POST-OPERATIVELY. THE SCREW WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644952 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- 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