OZARK Cervical Plate System AA01-43F60VRecalls & reported problems
VB Spine LLC · Plate, 3 Level Size 60 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857402034), received between Jan 11, 2023 and Mar 3, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Fracture; Migration
MalfunctionNov 21, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING COVER OF AN OZARK PLATE FRACTURED APPROXIMATELY 8 MONTHS POST-OPERATIVELY, AND THAT TWO OZARK VARIABLE SCREWS MIGRATED AT THE SAME LEVEL. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR THE OZARK PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20754461 ↗InjuryJan 11, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A FRACTURED LOCKING MECHANISM ON A THREE-LEVEL OZARK PLATE. THE FRACTURED COMPONENT WAS REMOVED FROM THE PATIENT AND THE PLATE WAS LEFT IN PLACE AS FUSION IS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16139298 ↗
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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