OZARK Cervical Plate System 8801-14016DARecalls & reported problems
VB Spine LLC · Fixed Screw, Self-Starting 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857392366), received between Feb 17, 2021 and May 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT TWO OZARK SELF-STARTING SCREWS AT C6 HAVE FRACTURED AND THE LOCKING MECHANISM OF AN OZARK PLATE AT THAT SAME LEVEL HAS DISENGAGED. THE PATIENT IS ASYMPTOMATIC AND REVISION SURGERY IS NOT PLANNED. THIS REPORT CAPTURES THE FIRST OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274361 ↗MalfunctionMay 8, 2024Fracture; Migration; Fracture; Migration
IT WAS REPORTED THAT TWO OZARK SELF-STARTING SCREWS AT C6 HAVE FRACTURED AND THE LOCKING MECHANISM OF AN OZARK PLATE AT THAT SAME LEVEL HAS DISENGAGED. THE PATIENT IS ASYMPTOMATIC AND REVISION SURGERY IS NOT PLANNED. THIS REPORT CAPTURES THE SECOND OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274358 ↗MalfunctionFeb 17, 2021Fracture
IT WAS REPORTED THAT TWO OZARK FIXED SCREWS AT C6 FRACTURED APPROXIMATELY 6 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11340016 ↗MalfunctionFeb 17, 2021Fracture
IT WAS REPORTED THAT TWO OZARK FIXED SCREWS AT C6 FRACTURED APPROXIMATELY 6 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11340004 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- 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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