OZARK Cervical Plate System 8801-04016DARecalls & reported problems
VB Spine LLC · Self-Starting, Variable Screw Size Ø4.0x16 mm · Class 2 · Implant
All models of OZARK Cervical Plate System (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The Ozark Cervical Plate is a spinal implant used to hold the neck vertebrae steady after surgery. There are 43 reports, mostly describing screws in the plate breaking, sometimes along with the locking mechanism coming loose, which several patients found after neck or back pain and imaging led to revision surgery; 24 injuries and no deaths were reported. 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
- 44
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10888857393387), received between Mar 18, 2020 and Jul 10, 2026 — classified as 24 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (40 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
- Fracture40
- Adverse Event Without Identified Device or Use Problem6
- Migration6
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Neck Pain14
- No Consequences Or Impact To Patient10
- Pain4
- Injury2
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25780962 ↗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 ↗InjuryNov 21, 2023Fracture; Material Deformation; Fracture; Material Deformation
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS DISENGAGEMENT OF THE LOCKING MECHANISM OF AN OZARK PLATE AT C7 AND BILATERAL OZARK SCREW FRACTURES AT C3 AND C7. THE PATIENT REPORTED BACK PAIN AND SUBSEQUENT IMAGING IDENTIFIED THE DISENGAGED OR FRACTURED HARDWARE. THIS REPORT CAPTURES THE SECOND OF FOUR OZARK SCREWS.
Patient problems: Pain
MAUDE report 18185525 ↗InjuryNov 21, 2023Fracture; Material Deformation; Fracture; Material Deformation
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS DISENGAGEMENT OF THE LOCKING MECHANISM OF AN OZARK PLATE AT C7 AND BILATERAL OZARK SCREW FRACTURES AT C3 AND C7. THE PATIENT REPORTED BACK PAIN AND SUBSEQUENT IMAGING IDENTIFIED THE DISENGAGED OR FRACTURED HARDWARE. THIS REPORT CAPTURES THE FIRST OF FOUR OZARK SCREWS.
Patient problems: Pain
MAUDE report 18185521 ↗InjurySep 5, 2023Fracture; Fracture
A PATIENT WAS REVISED TO PROVIDE SUPPLEMENTAL FIXATION FOLLOWING FRACTURE OF TWO OZARK SCREWS. ONE OZARK SCREW AT C7 WAS NOTED TO HAVE FRACTURED APPROXIMATELY 6-MONTHS POST-OPERATIVELY; ONE OZARK SCREW AT C4 WAS NOTED TO HAVE FRACTURED APPROXIMATELY 26-MONTHS POST-OPERATIVELY. THE DEVICES REMAIN IMPLANTED. THIS REPORT CAPTURES THE FRACTURED OZARK SCREW AT C7.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17684873 ↗InjurySep 5, 2023Fracture; Fracture
A PATIENT WAS REVISED TO PROVIDE SUPPLEMENTAL FIXATION FOLLOWING FRACTURE OF TWO OZARK SCREWS. ONE OZARK SCREW AT C7 WAS NOTED TO HAVE FRACTURED APPROXIMATELY 6-MONTHS POST-OPERATIVELY; ONE OZARK SCREW AT C4 WAS NOTED TO HAVE FRACTURED APPROXIMATELY 26-MONTHS POST-OPERATIVELY. THE DEVICES REMAIN IMPLANTED. THIS REPORT CAPTURES THE FRACTURED OZARK SCREW AT C4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17684702 ↗InjuryFeb 27, 2023Fracture; Migration; Fracture; Migration
A PATIENT REPORTED NECK PAIN AND IMAGING IDENTIFIED TWO FRACTURED OZARK SELF-STARTING SCREWS. THE PATIENT WAS REVISED, THE FRACTURED SCREWS WERE LEFT IN PLACE, AND POSTERIOR FIXATION WAS ADDED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED OZARK SCREWS.
Patient problems: Pain
MAUDE report 16449622 ↗InjuryFeb 27, 2023Fracture; Migration; Fracture; Migration
A PATIENT REPORTED NECK PAIN AND IMAGING IDENTIFIED TWO FRACTURED OZARK SELF-STARTING SCREWS. THE PATIENT WAS REVISED, THE FRACTURED SCREWS WERE LEFT IN PLACE, AND POSTERIOR FIXATION WAS ADDED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED OZARK SCREWS.
Patient problems: Pain
MAUDE report 16449550 ↗InjuryJan 20, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF AN OZARK PLATE BROKE AT THE C7 SCREW LEVEL AND TWO OZARK SELF-STARTING, VARIABLE SCREWS MIGRATED. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE FIRST OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16214539 ↗InjuryJan 20, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF AN OZARK PLATE BROKE AT THE C7 SCREW LEVEL AND TWO OZARK SELF-STARTING, VARIABLE SCREWS MIGRATED. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE SECOND OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16214537 ↗MalfunctionJul 9, 2021Fracture; Fracture
IT WAS REPORTED ON FOLLOW UP X-RAY, THAT 2 OZARK SELF STARTING SCREWS, BILATERAL FRACTURE AT DISTAL END OF CONSTRUCT. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12143462 ↗MalfunctionJul 9, 2021Fracture; Fracture
IT WAS REPORTED ON FOLLOW UP X-RAY, THAT 2 OZARK SELF STARTING SCREWS, BILATERAL FRACTURE AT DISTAL END OF CONSTRUCT. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12143342 ↗MalfunctionOct 14, 2020Fracture; Fracture
A PHYSICIAN REPORTED FOUR FRACTURED OZARK SCREWS AT THE C3 TO C7 LEVELS IDENTIFIED APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. THIS REPORT REPRESENTS THE SECOND OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10680204 ↗MalfunctionOct 14, 2020Fracture; Fracture
A PHYSICIAN REPORTED FOUR FRACTURED OZARK SCREWS AT THE C3 TO C7 LEVELS IDENTIFIED APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. THIS REPORT REPRESENTS THE THIRD OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10680177 ↗MalfunctionOct 14, 2020Fracture; Fracture
A PHYSICIAN REPORTED FOUR FRACTURED OZARK SCREWS AT THE C3 TO C7 LEVELS IDENTIFIED APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. THIS REPORT REPRESENTS THE FOURTH OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10679831 ↗MalfunctionOct 14, 2020Fracture; Fracture
A PHYSICIAN REPORTED FOUR FRACTURED OZARK SCREWS AT THE C3 TO C7 LEVELS IDENTIFIED APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. THIS REPORT REPRESENTS THE FIRST OF FOUR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10679028 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
FOLLOWING THE VISUAL INSPECTION OF RECEIVED RADIOGRAPHIC IMAGES, IT WAS CONFIRMED THAT ONLY TWO SCREWS FRACTURED. THE COMPLAINT SCREWS ARE CAPTURED UNDER REPORTS 3004774118-2020-00173 AND 3004774118-2020-00174. THEREFORE, THIS OZARK SELF-STARTING VARIABLE SCREW IS CONCOMITANT.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399320 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
FOLLOWING THE VISUAL INSPECTION OF RECEIVED RADIOGRAPHIC IMAGES, IT WAS CONFIRMED THAT ONLY TWO SCREWS FRACTURED. THE COMPLAINT SCREWS ARE CAPTURED UNDER REPORTS 3004774118-2020-00173 AND 3004774118-2020-00174. THEREFORE, THIS OZARK SELF-STARTING VARIABLE SCREW IS CONCOMITANT.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399319 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
FOLLOWING THE VISUAL INSPECTION OF RECEIVED RADIOGRAPHIC IMAGES, IT WAS CONFIRMED THAT ONLY TWO SCREWS FRACTURED. THE COMPLAINT SCREWS ARE CAPTURED UNDER REPORTS 3004774118-2020-00173 AND 3004774118-2020-00174. THEREFORE, THIS OZARK SELF-STARTING VARIABLE SCREW IS CONCOMITANT.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399318 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF OZARK SELF-STARTING, VARIABLE SCREWS FRACTURED 4-6 MONTHS POST-OPERATIVELY. THE PATIENT IS NOW EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. AS EIGHT SCREWS WERE IMPLANTED DURING INDEX SURGERY SPANNING C4, C5, C6, AND C7, ALL EIGHT SCREWS WILL BE REPORTED CONSERVATIVELY. THIS RECORD CAPTURES THE FIFTH OF EIGHT SCREWS.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399314 ↗InjuryAug 12, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SELF-STARTING, VARIABLE SCREWS FRACTURED 4-6 MONTHS POST-OPERATIVELY. THE PATIENT IS NOW EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. THIS RECORD CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Neck Pain
MAUDE report 10399252 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF OZARK SELF-STARTING, VARIABLE SCREWS FRACTURED 4-6 MONTHS POST-OPERATIVELY. THE PATIENT IS NOW EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. AS EIGHT SCREWS WERE IMPLANTED DURING INDEX SURGERY SPANNING C4, C5, C6, AND C7, ALL EIGHT SCREWS WILL BE REPORTED CONSERVATIVELY. THIS RECORD CAPTURES THE FOURTH OF EIGHT SCREWS.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399246 ↗InjuryAug 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF OZARK SELF-STARTING, VARIABLE SCREWS FRACTURED 4-6 MONTHS POST-OPERATIVELY. THE PATIENT IS NOW EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. AS EIGHT SCREWS WERE IMPLANTED DURING INDEX SURGERY SPANNING C4, C5, C6, AND C7, ALL EIGHT SCREWS WILL BE REPORTED CONSERVATIVELY. THIS RECORD CAPTURES THE THIRD OF EIGHT SCREWS.
Patient problems: Neck Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 10399244 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page