OZARK Cervical Plate System 8801-04514DARecalls & reported problems
VB Spine LLC · Self-Starting, Variable Screw Size Ø4.5x14 mm · Class 2 · Implant
All models of OZARK Cervical Plate System (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857393707), received between Apr 1, 2022 and Dec 13, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Migration” (5 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.
Most reported problems
Device problems
- Migration5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 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 FIRST OF FOUR MIGRATED OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965793 ↗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 THIRD OF FOUR MIGRATED OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965528 ↗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 SECOND OF FOUR MIGRATED OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15964299 ↗InjuryApr 1, 2022Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TWO MIGRATED OZARK SELF-STARTING VARIABLE SCREWS AT T1 AND AN OZARK FIVE-LEVEL PLATE WITH A DISENGAGED SECURING MECHANISM AT LEVELS C3 AND T1. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED OZARK SELF-STARTING VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978600 ↗InjuryApr 1, 2022Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TWO MIGRATED OZARK SELF-STARTING VARIABLE SCREWS AT T1 AND AN OZARK FIVE-LEVEL PLATE WITH A DISENGAGED SECURING MECHANISM AT LEVELS C3 AND T1. THIS REPORT CAPTURES THE FIRST OF TWO MIGRATED OZARK SELF-STARTING VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978457 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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.
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