OZARK Cervical Plate System 8801-04018DARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888857393400), received between Feb 26, 2020 and May 29, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO OZARK VARIABLE SELF-STARTING SCREWS FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED SCREW SHANKS REMAIN IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106361 ↗
• MalfunctionDec 1, 2023Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  A COMPANY REPRESENTATIVE REPORTED THAT THREE OZARK SELF-STARTING SCREWS HAVE FRACTURED APPROXIMATELY THREE-MONTHS AFTER IMPLANTATION; TWO SCREWS AT C7, ONE SCREW AT C6. REVISION SURGERY IS NOT CURRENTLY PLANNED. THIS REPORT CAPTURES THE SECOND OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246882 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THREE OZARK SELF-STARTING SCREWS HAVE FRACTURED APPROXIMATELY THREE-MONTHS AFTER IMPLANTATION; TWO SCREWS AT C7, ONE SCREW AT C6. REVISION SURGERY IS NOT CURRENTLY PLANNED. THIS REPORT CAPTURES THE FIRST OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243630 ↗
• MalfunctionNov 30, 2023Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  A COMPANY REPRESENTATIVE REPORTED THAT THREE OZARK SELF-STARTING SCREWS HAVE FRACTURED APPROXIMATELY THREE-MONTHS AFTER IMPLANTATION; TWO SCREWS AT C7, ONE SCREW AT C6. REVISION SURGERY IS NOT CURRENTLY PLANNED. THIS REPORT CAPTURES THE THIRD OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243629 ↗
• InjuryNov 21, 2023Fracture; Material Deformation; Fracture; Material Deformation

  A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS DISENGAGEMENT OF THE LOCKING MECHANISM OF AN OZARK PLATE AT C7 AND BILATERAL OZARK SCREW FRACTURES AT C3 AND C7. THE PATIENT REPORTED BACK PAIN AND SUBSEQUENT IMAGING IDENTIFIED THE DISENGAGED OR FRACTURED HARDWARE. THIS REPORT CAPTURES THE THIRD OF FOUR OZARK SCREWS.

  Patient problems: Pain

  MAUDE report 18185524 ↗
• InjuryNov 21, 2023Fracture; Material Deformation; Fracture; Material Deformation

  A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS DISENGAGEMENT OF THE LOCKING MECHANISM OF AN OZARK PLATE AT C7 AND BILATERAL OZARK SCREW FRACTURES AT C3 AND C7. THE PATIENT REPORTED BACK PAIN AND SUBSEQUENT IMAGING IDENTIFIED THE DISENGAGED OR FRACTURED HARDWARE. THIS REPORT CAPTURES THE FOURTH OF FOUR OZARK SCREWS.

  Patient problems: Pain

  MAUDE report 18185522 ↗
• InjuryMay 4, 2023Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF AN OZARK PLATE FAILED AND TWO OZARK SELF-STARTING, VARIABLE SCREWS MIGRATED. THE PATIENT WAS REVISED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867997 ↗
• InjuryMay 4, 2023Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF AN OZARK PLATE FAILED AND TWO OZARK SELF-STARTING, VARIABLE SCREWS MIGRATED. THE PATIENT WAS REVISED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867988 ↗
• MalfunctionApr 18, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT APPROXIMATELY 6 MONTHS POST-OPERATIVELY AN OZARK SELF-STARTING, VARIABLE SCREW AT C2 FRACTURED. THERE ARE NO PLANS TO REVISE THE PATIENT WHO IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762137 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE OZARK SELF-STARTING VARIABLE SCREW FRACTURE. IN ONE INSTANCE, THE FRACTURED SHAFT OF THE DEVICE REMAINS IMPLANTED IN THE PATIENT'S BONE. IN BOTH INSTANCES, THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136256 ↗
• InjuryJan 31, 2022Fracture; Fracture

  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 FIRST OF TWO OZARK SELF-TAPPING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13399727 ↗
• InjuryJan 31, 2022Fracture; Fracture

  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 SECOND OF TWO OZARK SELF-TAPPING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13399674 ↗
• InjuryFeb 26, 2020Fracture; Fracture

  PHYSICIAN REPORTED THAT 2 OZARK VIEW SELF-STARTING, VARIABLE SCREWS; SIZE Ø4.0X18 MM BACKED OUT 1-3 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.

  Patient problems: Injury; No Consequences Or Impact To Patient; Pain

  MAUDE report 9759409 ↗
• InjuryFeb 26, 2020Fracture; Fracture

  PHYSICIAN REPORTED THAT 2 OZARK VIEW SELF-STARTING, VARIABLE SCREWS; SIZE Ø4.0X18 MM BACKED OUT 1-3 MONTHS POSTOPERATIVELY. REVISION SURGERY HAS OCCURRED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: Injury; No Consequences Or Impact To Patient; Pain

  MAUDE report 9758997 ↗