OZARK Cervical Plate System 8801-90074Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857404120), received between May 23, 2022 and Aug 30, 2022 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN OZARK TAPERED DRIVER SHAFT WAS DETACHING FROM THE OZARK STREAMLINE SPIN CAP HANDLE INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE TAPERED DRIVER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320311 ↗
• MalfunctionJul 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN OZARK CERVICAL PLATE SYSTEM TAPERED DRIVER WAS NOT HOLDING SCREWS INTRA-OPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029390 ↗
• MalfunctionJun 22, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT AN OZARK TAPERED DRIVER TIP WAS FOUND TO BE WORN PRIOR TO SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14780196 ↗
• MalfunctionMay 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN OZARK SCREWDRIVER BROKE OFF INTRA-OPERATIVELY. THE TIP WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14474762 ↗