OZARK Cervical Plate System 8801-04014DARecalls & reported problems
VB Spine LLC · Self-Starting, Variable Screw Size Ø4.0x14 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
This VB Spine Ozark cervical plate and screw system is used to hold the neck spine steady after surgery. Most of the 39 reports describe the plate's locking mechanism breaking and screws breaking or shifting out of place, sometimes months after implantation and leading to pain and a second operation to remove or revise the implants; 15 reports involve injuries and none describe deaths. 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
- 40
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10888857393363), received between Mar 18, 2020 and Jul 10, 2026 — classified as 15 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Fracture” (28 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
- Fracture28
- Migration14
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Pain7
- No Consequences Or Impact To Patient4
- Injury1
- Neck Pain1
Recent adverse event reports
The 25 most recent of 40 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 25781041 ↗InjuryNov 27, 2024Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799130 ↗InjuryNov 27, 2024Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20799087 ↗InjuryMay 29, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH PAIN WAS REVISED APPROXIMATELY 6 MONTHS POST-OPERATIVELY TO ADDRESS ONE MIGRATED OZARK SELF-STARTING, VARIABLE SCREW AT C6 AND ONE OZARK PLATE WITH A FRACTURED LOCKING MECHANISM. THIS REPORT CAPTURES THE SCREW.
Patient problems: Pain
MAUDE report 19415698 ↗InjurySep 1, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED OZARK SCREWS AND AN OZARK PLATE WITH A DISENGAGED LOCKING MECHANISM. THIS REPORT CAPTURES THE FIRST OF TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17670974 ↗InjuryAug 31, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED OZARK SCREWS AND AN OZARK PLATE WITH A DISENGAGED LOCKING MECHANISM. THIS REPORT CAPTURES THE SECOND OF TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667070 ↗InjuryDec 12, 2022Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISMS AT TWO LEVELS OF A FOUR-LEVEL OZARK PLATE FRACTURED, ONE OZARK SCREW FRACTURED, AND FOUR OZARK SCREWS MIGRATED. THE PATIENT ACHIEVED FUSION AND WAS REVISED TO REMOVE THE IMPLANTS. THIS REPORT CAPTURES THE FRACTURED OZARK SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965438 ↗InjuryDec 12, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISMS AT TWO LEVELS OF A FOUR-LEVEL OZARK PLATE FRACTURED, ONE OZARK SCREW FRACTURED, AND FOUR OZARK SCREWS MIGRATED. THE PATIENT ACHIEVED FUSION AND WAS REVISED TO REMOVE THE IMPLANTS. THIS REPORT CAPTURES THE FOURTH OF FOUR MIGRATED OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15964312 ↗InjuryJun 20, 2022Fracture; Fracture
A PATIENT REPORTED THAT THEY WERE EXPERIENCING PAIN APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. IMAGING WAS PERFORMED AND THE PHYSICIAN REPORTED THAT FOUR OZARK CERVICAL SCREWS HAD FRACTURED AND THE OZARK CERVICAL PLATE SECURING MECHANISM HAD DISENGAGED AT C3. THE PHYSICIAN INDICATES THAT THE PATIENT APPEARS TO HAVE ACHIEVED FUSION AND REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED. THIS REPORT CAPTURES THE FOURTH OF FOUR OZARK CERVICAL SCREWS.
Patient problems: Pain
MAUDE report 14745914 ↗MalfunctionJun 20, 2022Fracture; Fracture
A PATIENT REPORTED THAT THEY WERE EXPERIENCING PAIN APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. IMAGING WAS PERFORMED AND THE PHYSICIAN REPORTED THAT FOUR OZARK CERVICAL SCREWS HAD FRACTURED AND THE OZARK CERVICAL PLATE SECURING MECHANISM HAD DISENGAGED AT C3. THE PHYSICIAN INDICATES THAT THE PATIENT APPEARS TO HAVE ACHIEVED FUSION AND REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED. THIS REPORT CAPTURES THE FIRST OF FOUR OZARK CERVICAL SCREWS.
Patient problems: Pain
MAUDE report 14745867 ↗InjuryJun 20, 2022Fracture; Fracture
A PATIENT REPORTED THAT THEY WERE EXPERIENCING PAIN APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. IMAGING WAS PERFORMED AND THE PHYSICIAN REPORTED THAT FOUR OZARK CERVICAL SCREWS HAD FRACTURED AND THE OZARK CERVICAL PLATE SECURING MECHANISM HAD DISENGAGED AT C3. THE PHYSICIAN INDICATES THAT THE PATIENT APPEARS TO HAVE ACHIEVED FUSION AND REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED. THIS REPORT CAPTURES THE THIRD OF FOUR OZARK CERVICAL SCREWS.
Patient problems: Pain
MAUDE report 14745866 ↗InjuryJun 20, 2022Fracture; Fracture
A PATIENT REPORTED THAT THEY WERE EXPERIENCING PAIN APPROXIMATELY FIVE MONTHS POST-OPERATIVELY. IMAGING WAS PERFORMED AND THE PHYSICIAN REPORTED THAT FOUR OZARK CERVICAL SCREWS HAD FRACTURED AND THE OZARK CERVICAL PLATE SECURING MECHANISM HAD DISENGAGED AT C3. THE PHYSICIAN INDICATES THAT THE PATIENT APPEARS TO HAVE ACHIEVED FUSION AND REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED. THIS REPORT CAPTURES THE SECOND OF FOUR OZARK CERVICAL SCREWS.
Patient problems: Pain
MAUDE report 14745859 ↗MalfunctionJun 14, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C6 FRACTURED APPROXIMATELY 4 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE SECOND SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691334 ↗MalfunctionJun 14, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C6 FRACTURED APPROXIMATELY 4 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE FIRST SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691320 ↗MalfunctionMay 27, 2022Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT THE LOCKING MECHANISM OF A 3 LEVEL OZARK CERVICAL PLATE AT C7 SEPARATED FROM THE PLATE POST-OPERATIVELY. SUBSEQUENTLY, THE TWO SCREWS AT THAT LEVEL MIGRATED AND FRACTURED. FUSION WAS ACHIEVED. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FIRST SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14523514 ↗MalfunctionMay 27, 2022Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT THE LOCKING MECHANISM OF A 3 LEVEL OZARK CERVICAL PLATE AT C7 SEPARATED FROM THE PLATE POST-OPERATIVELY. SUBSEQUENTLY, THE TWO SCREWS AT THAT LEVEL MIGRATED AND FRACTURED. FUSION WAS ACHIEVED. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE SECOND SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14523513 ↗MalfunctionJan 10, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C6 FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13207074 ↗MalfunctionJan 10, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C6 FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13206981 ↗MalfunctionJan 10, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C7 FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13206689 ↗MalfunctionJan 10, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SCREWS AT C7 FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13206494 ↗MalfunctionOct 26, 2021Migration; Migration
IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN OZARK PLATE AT C5 FRACTURED AND TWO OZARK SCREWS MIGRATED POST-OPERATIVELY. 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 12698869 ↗MalfunctionOct 26, 2021Migration; Migration
IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN OZARK PLATE AT C5 FRACTURED AND TWO OZARK SCREWS MIGRATED POST-OPERATIVELY. 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 12698865 ↗MalfunctionOct 21, 2021Fracture; Fracture
IT WAS REPORTED THAT THE THREAD OF AN OZARK SELF-STARTING VARIABLE SCREW STRIPPED DURING INSERTION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SCREW. NO ADVERSE CONSEQUENCES NOR SURGICAL DELAY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12677426 ↗MalfunctionMar 2, 2021Fracture; Fracture
A PHYSICIAN REPORTED A FRACTURED OZARK SCREW AT C4 APPROXIMATELY SEVEN MONTHS AFTER IMPLANT. REVISION SURGERY HAS NOT BEEN SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398368 ↗MalfunctionJan 22, 2021Fracture; Fracture
IT WAS REPORTED THAT AN OZARK VARIABLE SCREW FRACTURED AT C7 APPROXIMATELY 6 MONTHS POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11219583 ↗
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