OZARK Cervical Plate System 8801-04016CARecalls & reported problems
VB Spine LLC · Self-Tapping, Variable Screw Size Ø4.0x16 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
- 20
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888857392878), received between Sep 3, 2020 and Nov 21, 2024 — classified as 4 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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.
Reports received per month
Most reported problems
Device problems
- Fracture15
- Migration5
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING COVER OF AN OZARK PLATE FRACTURED APPROXIMATELY 8 MONTHS POST-OPERATIVELY, AND THAT TWO OZARK VARIABLE SCREWS MIGRATED AT THE SAME LEVEL. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR THE SECOND OF TWO OZARK VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20754464 ↗MalfunctionNov 21, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING COVER OF AN OZARK PLATE FRACTURED APPROXIMATELY 8 MONTHS POST-OPERATIVELY, AND THAT TWO OZARK VARIABLE SCREWS MIGRATED AT THE SAME LEVEL. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR THE FIRST OF TWO OZARK VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20754460 ↗MalfunctionFeb 3, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISM OF A TWO-LEVEL OZARK PLATE DISENGAGED AT C6 AND AN OZARK SELF-TAPPING SCREW AT THAT LEVEL MIGRATED. THE PATIENT HAS NOT BEEN REVISED. THIS REPORT CAPTURES THE OZARK SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16300254 ↗MalfunctionFeb 1, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF A TWO-LEVEL OZARK PLATE DISENGAGED AT C6 AND TWO OZARK SELF-TAPPING SCREWS AT THAT SAME LEVEL MIGRATED. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16281149 ↗MalfunctionFeb 1, 2023Migration; Migration
B5: IT WAS REPORTED THAT APPROXIMATELY SIX-MONTHS POST-OPERATIVELY THE LOCKING MECHANISM OF A TWO-LEVEL OZARK PLATE DISENGAGED AT C6 AND TWO OZARK SELF-TAPPING SCREWS AT THAT SAME LEVEL MIGRATED. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16281141 ↗InjuryOct 7, 2021Fracture; Fracture
IT WAS REPORTED THAT AN OZARK SELF-TAPPING SCREW FRACTURED POST-OPERATIVELY. UPON REVIEW OF PROVIDED IMAGING, A SECOND SCREW WAS OBSERVED TO BE FRACTURED, ALONG WITH SECURING MECHANISM OF THE OZARK PLATE. REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION, HOWEVER, THE FRACTURED DEVICES WERE LEFT IN PLACE. THIS RECORD CAPTURES THE FIRST OF THE TWO OZARK SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12593075 ↗InjuryOct 7, 2021Fracture; Fracture
IT WAS REPORTED THAT AN OZARK SELF-TAPPING SCREW FRACTURED POST-OPERATIVELY. UPON REVIEW OF PROVIDED IMAGING, A SECOND SCREW WAS OBSERVED TO BE FRACTURED, ALONG WITH SECURING MECHANISM OF THE OZARK PLATE. REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION, HOWEVER, THE FRACTURED DEVICES WERE LEFT IN PLACE. THIS RECORD CAPTURES THE SECOND OF THE TWO OZARK SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12593003 ↗InjuryOct 6, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SELF-TAPPING VARIABLE SCREWS FRACTURED SEVERAL MONTHS POST-OPERATIVELY DUE TO EXTERNAL TRAUMA (PATIENT FELL). UPON REVIEW OF PROVIDED IMAGING, IT WAS NOTED THAT THE SECURING MECHANISM OF THE OZARK PLATE FRACTURED AS WELL. THE FRACTURED DEVICES WERE LEFT IN PLACE, HOWEVER, REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12586873 ↗InjuryOct 6, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK SELF-TAPPING VARIABLE SCREWS FRACTURED SEVERAL MONTHS POST-OPERATIVELY DUE TO EXTERNAL TRAUMA (PATIENT FELL). UPON REVIEW OF PROVIDED IMAGING, IT WAS NOTED THAT THE SECURING MECHANISM OF THE OZARK PLATE FRACTURED AS WELL. THE FRACTURED DEVICES WERE LEFT IN PLACE, HOWEVER, REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12586872 ↗MalfunctionOct 4, 2021Fracture; Fracture
IT WAS REPORTED POST-OPERATIVELY BY X-RAY THAT AN OZARK SELF TAPPING VARIABLE SCREW WAS FRACTURED. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12573555 ↗MalfunctionOct 4, 2021Fracture; Fracture
IT WAS REPORTED POST-OPERATIVELY BY X-RAY THAT AN OZARK SELF TAPPING VARIABLE SCREW WAS FRACTURED. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12573531 ↗MalfunctionMar 2, 2021Fracture; Fracture
A PHYSICIAN REPORTED TWO FRACTURED OZARK SCREWS WERE NOTED VIA X-RAY APPROXIMATELY SEVEN MONTHS AFTER IMPLANTATION. THE PATIENT IS FUSING AND REVISION IS NOT PLANNED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398937 ↗MalfunctionMar 2, 2021Fracture; Fracture
A PHYSICIAN REPORTED TWO FRACTURED OZARK SCREWS WERE NOTED VIA X-RAY APPROXIMATELY SEVEN MONTHS AFTER IMPLANTATION. THE PATIENT IS FUSING AND REVISION IS NOT PLANNED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11398920 ↗MalfunctionFeb 10, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK VARIABLE SCREWS AT C6 FRACTURED APPROXIMATELY 3 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. FUSION WAS NOT ACHIEVED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11309565 ↗MalfunctionFeb 10, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO OZARK VARIABLE SCREWS AT C6 FRACTURED APPROXIMATELY 3 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. FUSION WAS NOT ACHIEVED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11309564 ↗MalfunctionNov 23, 2020Fracture; Fracture
A PHYSICIAN REPORTED THAT TWO OZARK SELF-TAPPING SCREWS AT THE BOTTOM OF A 4-LEVEL OZARK PLATE WERE FOUND TO BE FRACTURED DURING THE PATIENT'S SCHEDULED, 3-MONTH FOLLOW-UP VISIT. THE PATIENT IS REPORTED TO HAVE FUSED AND REVISION IS NOT PLANNED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10884871 ↗MalfunctionNov 23, 2020Fracture; Fracture
A PHYSICIAN REPORTED THAT TWO OZARK SELF-TAPPING SCREWS AT THE BOTTOM OF A 4-LEVEL OZARK PLATE WERE FOUND TO BE FRACTURED DURING THE PATIENT'S SCHEDULED, 3-MONTH FOLLOW-UP VISIT. THE PATIENT IS REPORTED TO HAVE FUSED AND REVISION IS NOT PLANNED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10884859 ↗MalfunctionOct 7, 2020Fracture; Fracture
A PHYSICIAN REPORTED TWO FRACTURED OZARK SCREWS AT THE C7 LEVEL APPROXIMATELY ONE YEAR AFTER IMPLANTATION. REVISION STATUS IS NOT CURRENTLY KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10642476 ↗MalfunctionOct 7, 2020Fracture; Fracture
A PHYSICIAN REPORTED TWO FRACTURED OZARK SCREWS AT THE C7 LEVEL APPROXIMATELY ONE YEAR AFTER IMPLANTATION. REVISION STATUS IS NOT CURRENTLY KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10642465 ↗MalfunctionSep 3, 2020Fracture; Fracture
A PHYSICIAN REPORTED THAT AN OZARK VIEW SELF-TAPPING SCREW IN C6 WAS OBSERVED TO BE FRACTURED IN A POST-OPERATIVE X-RAY APPROXIMATELY FOUR TO SIX-MONTHS AFTER IMPLANTATION. REVISION SURGERY HAS NOT BEEN SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10488805 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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