OZARK Cervical Plate System 8801-90034Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10888857400863), received between Mar 26, 2021 and Apr 4, 2025 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fracture” (30 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777922 ↗
• MalfunctionApr 4, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777920 ↗
• 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 SCREWDRIVER FRACTURE WHICH OCCURRED DURING THE SAME SURGERY. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136100 ↗
• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE OZARK SCREWDRIVER TIP DEFORMATION. 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 15136074 ↗
• MalfunctionMay 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING REMOVAL OF A PLATE TWO OZARK SCREWDRIVERS BECAME BROKEN AND UNUSABLE AT THE TIP. THIS REPORT CAPTURES THE FIRST SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522147 ↗
• MalfunctionMay 27, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING REMOVAL OF A PLATE TWO OZARK SCREWDRIVERS BECAME BROKEN AND UNUSABLE AT THE TIP. THIS REPORT CAPTURES THE SECOND SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522142 ↗
• MalfunctionMay 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN OZARK SCREWDRIVER FRACTURED DURING INTRA-OPERATIVE SCREW INSERTION. 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 14322055 ↗
• MalfunctionApr 6, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF AN OZARK SCREWDRIVER FRACTURED. THE REPORTED EVENT WAS NOTED DURING INSPECTION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021741 ↗
• MalfunctionMar 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN OZARK SCREW DRIVER BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655337 ↗
• MalfunctionFeb 18, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE TIP OF AN OZARK SCREW DRIVER WOULDN'T RETAIN THE SCREW INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559477 ↗
• MalfunctionFeb 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO OZARK DRIVERS BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FIRST OF TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534972 ↗
• MalfunctionFeb 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT TWO OZARK DRIVERS BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534966 ↗
• MalfunctionJan 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIPS OF 2 OZARK SCREW DRIVERS FRACTURED OFF DURING INTRA-OPERATIVE SCREW INSERTION. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP AS IT IS NOW STUCK IN THE SCREW HEAD. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF THE TWO SCREW DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197205 ↗
• MalfunctionJan 7, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF 2 OZARK SCREW DRIVERS FRACTURED OFF DURING INTRA-OPERATIVE SCREW INSERTION. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP AS IT IS NOW STUCK IN THE SCREW HEAD. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREW DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197201 ↗
• MalfunctionDec 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SCREW IMPLANTATION, THE TIP OF AN OZARK SCREW DRIVER W/THREAD TWISTED. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957058 ↗
• MalfunctionNov 22, 2021Fracture; Material Deformation; Fracture; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT AN OZARK DRIVER WAS RECEIVED WITH A FRACTURED THREAD ON THE TIP. THE REPORTED EVENT WAS NOTED DURING INSPECTION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857660 ↗
• MalfunctionNov 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE OZARK THREADED SCREW DRIVER WAS OBSERVED TO BE DEFORMED UPON INSPECTION. THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT. NO SURGICAL DELAY NOR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844734 ↗
• MalfunctionNov 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN OZARK THREADED SCREW DRIVER FRACTURED DURING INTRA-OPERATIVE IMPLANT INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836021 ↗
• MalfunctionNov 2, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT 2 OZARK SCREWDRIVERS STRIPPED UPON SCREW INSERTION INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION. UPON REVIEW OF THE RETURNED DEVICE, IT WAS NOTICED THAT THE TIP WAS FRACTURED. THIS REPORT WILL CAPTURE THE FRACTURED SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740884 ↗
• MalfunctionNov 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 2 OZARK SCREWDRIVERS STRIPPED UPON SCREW INSERTION INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740881 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD OF AN OZARK THREADED SCREW DRIVER WAS 'MISSING' INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683100 ↗
• MalfunctionOct 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE SCREW INSERTION, THE TIP OF AN OZARK SCREWDRIVER BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVELY AVAILABLE DEVICE WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573113 ↗
• MalfunctionAug 12, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT AN OZARK SCREWDRIVER HAD NO THREAD TO LOAD SCREW ONTO DRIVER INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313509 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT 2 OZARK SCREWDRIVERS WERE BROKEN INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT CAPTURES THE SECOND OF TWO SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304775 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN OZARK SCREWDRIVER WAS BROKEN INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304695 ↗