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OZARK Cervical Plate System 8801-04018CARecalls & reported problems

VB Spine LLC · Self-Tapping, Variable Screw Size Ø4.0x18 mm · Class 2 · Implant

All models of OZARK Cervical Plate System (54)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857392892), received between Nov 23, 2020 and Jun 30, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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

Device problems

  • Fracture6

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

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

  • MalfunctionJun 30, 2022Fracture; Fracture

    A COMPANY REPRESENTATIVE REPORTED THAT TWO OZARK SCREWS AT C7 FRACTURED APPROXIMATELY 3 MONTHS POST-OPERATIVELY. AN UNKNOWN CAGE HAS ALSO MIGRATED ANTERIORLY. REVISION SURGERY WILL NOT BE PERFORMED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14875869 ↗
  • MalfunctionJun 30, 2022Fracture; Fracture

    A COMPANY REPRESENTATIVE REPORTED THAT TWO OZARK SCREWS AT C7 FRACTURED APPROXIMATELY 3 MONTHS POST-OPERATIVELY. AN UNKNOWN CAGE HAS ALSO MIGRATED ANTERIORLY. REVISION SURGERY WILL NOT BE PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14875806 ↗
  • MalfunctionJan 20, 2022Fracture; Fracture

    IT WAS REPORTED VIA X-RAY THAT 2 OZARK VIEW SELF-TAPPING SCREWS WERE OBSERVED TO BE FRACTURED VIA X-RAY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13311189 ↗
  • MalfunctionJan 20, 2022Fracture; Fracture

    IT WAS REPORTED VIA X-RAY THAT 2 OZARK VIEW SELF-TAPPING SCREWS WERE OBSERVED TO BE FRACTURED VIA X-RAY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13311186 ↗
  • MalfunctionNov 23, 2020Fracture; Fracture

    A PHYSICIAN REPORTED THAT, DURING A SCHEDULED THREE-MONTH POSTOPERATIVE FOLLOW-UP APPOINTMENT, X-RAYS SHOWED TWO OZARK SELF-TAPPING SCREWS TO BE FRACTURED AT THE INFERIOR LEVEL OF THE CONSTRUCT. REVISION STATUS IS CURRENTLY UNKNOWN. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10885516 ↗
  • MalfunctionNov 23, 2020Fracture; Fracture

    A PHYSICIAN REPORTED THAT, DURING A SCHEDULED THREE-MONTH POSTOPERATIVE FOLLOW-UP APPOINTMENT, X-RAYS SHOWED TWO OZARK SELF-TAPPING SCREWS TO BE FRACTURED AT THE INFERIOR LEVEL OF THE CONSTRUCT. REVISION STATUS IS CURRENTLY UNKNOWN. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10885484 ↗

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Sources and updates

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