OZARK Cervical Plate System AA01-43F57VRecalls & reported problems
VB Spine LLC · Plate, 3 Level Size 57 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857402003), received between Apr 12, 2022 and Nov 30, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated1
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED LOCKING MECHANISM ON A THREE-LEVEL OZARK PLATE. TWO OZARK SCREWS AT THE LEVEL OF THE FRACTURED LOCKING MECHANISM MIGRATED AND "BEGAN ERODING UNDER THE ESOPHAGUS." THIS REPORT CAPTURES THE THREE-LEVEL OZARK PLATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15885673 ↗MalfunctionAug 23, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT AT THE SIX MONTH FOLLOW UP, ONE (1) OZARK SELF-TAPPING, VARIABLE SCREW AT C7 HAS BACKED OUT BEYOND THE LOCKING MECHANISM OF THE OZARK PLATE. THE PATIENT IS DOING WELL, AND A REVISION SURGERY HAS NOT BEEN SCHEDULED. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE OZARK PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279899 ↗MalfunctionApr 12, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST-OPERATIVELY, THE SECURING MECHANISM OF AN OZARK PLATE FAILED CAUSING THE TWO OZARK SCREWS AT C7 TO MIGRATE. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED. THIS REPORT CAPTURES PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14084597 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page