PYRENEES® Cervical Plate System 201-14016DRecalls & reported problems
VB Spine LLC · Self-Starting Screw, Constrained Size Ø4.0x16 mm · Class 2 · Implant
All models of PYRENEES Cervical Plate System (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857027039), received between Mar 2, 2016 and Feb 20, 2026 — classified as 3 injuries, 2 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.
Reports received per month
Most reported problems
Device problems
- Migration4
- Device Issue1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Fracture; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408107 ↗InjuryFeb 20, 2026Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408106 ↗InjuryJul 17, 2023Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A PYRENEES SELF-STARTING SCREW MIGRATION ON THE RIGHT SIDE OF C3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17338949 ↗MalfunctionNov 4, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PYRENEES SELF-STARTING SCREW IS BACKING OUT. THE PATIENT IS IMPLANTED C4 TO C6 AND IT IS NOT YET KNOWN IF THEY WILL BE REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15739547 ↗MalfunctionMar 2, 2016Device Issue; Device Issue
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A SLIVER OF A SCREW PEELED OFF; THE SCREW WAS LEFT IN THE PATIENT AND THE SLIVER WAS REMOVED.
Patient problems: No Information
MAUDE report 5474488 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- 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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