OZARK Cervical Plate System AA01-42F40VRecalls & reported problems
VB Spine LLC · Plate, 2 Level Size 40 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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857401594), received between Feb 20, 2020 and Sep 17, 2026 — classified as 4 injuries, 2 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
- Material Deformation3
- Detachment of Device or Device Component1
- Mechanical Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Dysphagia/ Odynophagia1
- Injury1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Fracture; Migration
A company representative reported that a patient was revised approximately three months post-operatively to address a fractured and migrated Ozark 2 Level Plate locking cover and four migrated Ozark Self-Tapping Variable Screws. This report captures the Plate.
Patient problems: Insufficient Information
MAUDE report 50809816 ↗MalfunctionJan 21, 2026Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136020 ↗InjuryJun 29, 2023Fracture; Material Deformation; Fracture; Material Deformation
A PATIENT WAS REVISED APPROXIMATELY 6-MONTHS AFTER IMPLANTATION TO ADDRESS A FRACTURED LOCKING MECHANISM ON TWO-LEVEL OZARK PLATE AND TWO MIGRATED OZARK SCREWS AT THAT SAME LEVEL (C7). THE PATIENT WAS NOTED TO HAVE ACHIEVED FUSION AND THE EXPLANTED DEVICES WERE NOT REPLACED. THIS REPORT CAPTURES THE TWO-LEVEL OZARK PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17233431 ↗MalfunctionJan 25, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOCKING MECHANISM ON AN OZARK LEVEL 2 PLATE FRACTURED, AND TWO SCREWS APPEAR TO HAVE MIGRATED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED AT THIS TIME. REVISION SURGERY HAS NOT BEEN PERFORMED THUS FAR. THIS RECORD CAPTURES THE LOCKING MECHANISM FRACTURE OF THE OZARK PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13343475 ↗InjuryNov 3, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
A PATIENT PRESENTED WITH PAIN AND DIFFICULTY SWALLOWING APPROXIMATELY 9-MONTHS POST-OPERATIVELY. A SUBSEQUENT X-RAY REVEALED THAT AN OZARK SCREW AT C7 HAD BACKED OUT OF AN OZARK PLATE. THE PATIENT WAS REVISED AND A PCF WAS PERFORMED. THIS REPORT CAPTURES THE OZARK PLATE.
Patient problems: Dysphagia/ Odynophagia; Pain
MAUDE report 12749146 ↗InjuryFeb 20, 2020Material Deformation; Material Deformation
A PHYSICIAN REPORTED THAT AN OZARK VIEW 2 LEVEL PLATE LOCKING COVER FAILED 6 WEEKS POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.
Patient problems: Injury
MAUDE report 9734816 ↗
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.
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