OZARK Cervical Plate System AA01-42F38VRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888857401570), received between Aug 3, 2021 and May 29, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH PAIN WAS REVISED APPROXIMATELY 6 MONTHS POST-OPERATIVELY TO ADDRESS ONE MIGRATED OZARK SELF-STARTING, VARIABLE SCREW AT C6 AND ONE OZARK PLATE WITH A FRACTURED LOCKING MECHANISM. THIS REPORT CAPTURES THE PLATE.

  Patient problems: Pain

  MAUDE report 19415674 ↗
• InjuryAug 31, 2023Fracture; Detachment of Device or Device Component; Migration; Fracture; Detachment of Device or Device Component; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO MIGRATED OZARK SCREWS AND AN OZARK PLATE WITH A DISENGAGED LOCKING MECHANISM. THIS REPORT CAPTURES THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667069 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN OZARK PLATE DISENGAGED AT C5, AND THAT TWO OZARK SELF-TAPPING VARIABLE SCREWS HAVE BEGUN TO MIGRATE POST-OPERATIVELY AT THE SAME LEVEL. NO ADVERSE CONSEQUENCES WERE REPORTED. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME. THIS REPORT IS FOR THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674276 ↗
• MalfunctionFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISM OF A TWO-LEVEL OZARK PLATE DISENGAGED AT C6 AND AN OZARK SELF-TAPPING SCREW AT THAT LEVEL MIGRATED. THE PATIENT HAS NOT BEEN REVISED. THIS REPORT CAPTURES THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300172 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF A TWO-LEVEL OZARK PLATE DISENGAGED AT C6 AND TWO OZARK SELF-TAPPING SCREWS AT THAT SAME LEVEL MIGRATED. THIS REPORT CAPTURES THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281148 ↗
• InjuryJan 20, 2023Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF AN OZARK PLATE BROKE AT THE C7 SCREW LEVEL AND TWO OZARK SELF-STARTING, VARIABLE SCREWS MIGRATED. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214536 ↗
• InjuryJan 31, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT TWO OZARK SELF-STARTING VARIABLE SCREWS AT C6 FRACTURED AND THE SECURING MECHANISM OF AN OZARK TWO-LEVEL PLATE FRACTURED. THE PATIENT HAS BEEN REVISED. THIS REPORT CAPTURES THE OZARK PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13399757 ↗
• MalfunctionAug 3, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF AN OZARK LEVEL 2 PLATE WOULD NOT TURN INTRA-OPERATIVELY, DURING FINAL TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE PLATE. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268313 ↗