OZARK Cervical Plate System 8801-04014DA-G1Recalls & 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
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857408845), received between Dec 15, 2021 and Feb 17, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2022Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 6-MONTHS POST-OPERATIVELY A PATIENT PRESENTED WITH TWO FRACTURED OZARK SCREWS AT C7. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE FIRST SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13552749 ↗MalfunctionFeb 17, 2022Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 6-MONTHS POST-OPERATIVELY A PATIENT PRESENTED WITH TWO FRACTURED OZARK SCREWS AT C7. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE SECOND SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13552740 ↗MalfunctionDec 15, 2021Migration; Migration
IT WAS REPORTED THAT X-RAY IMAGING SHOWED SOMETHING PROTRUDING AT THE C4 LEVEL OF AN OZARK CONSTRUCT. THE OBSERVED ISSUE MAY HAVE BEEN DUE TO MIGRATED OZARK SCREWS OR A FRACTURED LOCKING MECHANISM OF THE OZARK PLATE. ADDITIONAL DETAILS REGARDING THIS EVENT ARE UNKNOWN AT THIS TIME. THIS RECORD CAPTURES THE FIRST OF THE TWO OZARK SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13014332 ↗
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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