OZARK Cervical Plate System AA01-42F42VRecalls & reported problems
VB Spine LLC · Plate, 2 Level Size 42 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 10888857401617), received between Apr 2, 2020 and Nov 21, 2024 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING COVER OF AN OZARK PLATE FRACTURED APPROXIMATELY 11 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20754715 ↗InjuryAug 31, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration; Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration
CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3) WITH 2 VIALS OF TEST STRIPS (REFERENCE (B)(4)). DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-3 ERROR USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31/2024 AND TEST STRIPS WERE OPENED TWO DAYS BEFORE THE CALL. THE CUSTOMER REPORTED FEELING DIZZY; CUSTOMER STATED HE WAS GOING TO SEE HIS DOCTOR AFTER THE CALL DUE TO THE DIZZINESS. CUSTOMER IS INSULIN DEPENDENT BUT HE DID NOT SPECIFY IF HE BASED THE DOSAGE OF INSULIN ON HIS RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667253 ↗InjuryApr 2, 2020Fracture; Fracture
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TWO FRACTURED OZARK SCREWS AT C5 AND A TWO-LEVEL OZARK PLATE WITH A FRACTURED SECURING MECHANISM. THIS REPORT CAPTURES THE TWO-LEVEL OZARK PLATE.
Patient problems: Pain
MAUDE report 9915921 ↗
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