OZARK Cervical Plate System 8801-04014CARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857392854), received between Oct 7, 2021 and Apr 4, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Migration; Migration

  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 ONE OF THE TWO OZARK SELF TAPPING VARIABLE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674305 ↗
• MalfunctionApr 4, 2023Migration; Migration

  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 ONE OF THE TWO OZARK SELF TAPPING VARIABLE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674303 ↗
• InjuryMar 9, 2023Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO-WEEKS POST-OPERATIVELY THE LOCKING MECHANISM OF A THREE-LEVEL OZARK PLATE DISENGAGED AND ONE OZARK SELF-TAPPING SCREW MIGRATED. THE PATIENT REPORTED PAIN AND DISCOMFORT. THIS REPORT CAPTURES THE SCREW.

  Patient problems: Pain

  MAUDE report 16517750 ↗
• MalfunctionAug 23, 2022Migration; Migration

  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 SELF-TAPPING VARIABLE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279898 ↗
• MalfunctionOct 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN OZARK SELF-TAPPING VARIABLE SCREW FRACTURED POST-OPERATIVELY. UPON REVIEW OF PROVIDED IMAGING, TWO OZARK SELF-TAPPING VARIABLE SCREW APPEAR TO BE FRACTURED. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12593065 ↗
• MalfunctionOct 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN OZARK SELF-TAPPING VARIABLE SCREW FRACTURED POST-OPERATIVELY. UPON REVIEW OF PROVIDED IMAGING, TWO OZARK SELF-TAPPING VARIABLE SCREW APPEAR TO BE FRACTURED. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12592988 ↗