PYRENEES® Cervical Plate System 201-14016CRecalls & reported problems
VB Spine LLC · Self-Tapping 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
- 10
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888857027022), received between Sep 3, 2021 and Feb 9, 2024 — classified as 3 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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
- Fracture9
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Nerve Damage2
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2024Fracture; Fracture
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY THREE MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED PYRENEES CONSTRAINED SELF-TAPPING SCREWS AT C7. THIS REPORT CAPTURES THE SECOND OF TWO PYRENEES CONSTRAINED SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18679118 ↗InjuryFeb 9, 2024Fracture; Fracture
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY THREE MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED PYRENEES CONSTRAINED SELF-TAPPING SCREWS AT C7. THIS REPORT CAPTURES THE FIRST OF TWO PYRENEES CONSTRAINED SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18679111 ↗InjuryApr 26, 2023Migration; Migration
A PATIENT REPORTED EXPERIENCING PAIN AND IMAGING INDICATED TWO PYRENEES SELF-TAPPING SCREWS HAD BACKED OUT. THE PATIENT WAS REVISED AND, DURING THE REVISION SURGERY, THE SURGEON ADDITIONALLY NOTED THAT THE PYRENEES PLATE WAS FRACTURED. THIS REPORT CAPTURES THE FIRST OF THE TWO MIGRATED SCREWS.
Patient problems: Pain
MAUDE report 16820695 ↗MalfunctionOct 1, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED POST-OPERATIVELY AT C6. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED PYRENEES SCREWS.
Patient problems: Nerve Damage
MAUDE report 12564138 ↗MalfunctionOct 1, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED POST-OPERATIVELY AT C6. REVISION SURGERY HAS NOT BEEN SCHEDULED NOR PERFORMED AT THIS TIME. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED PYRENEES SCREWS.
Patient problems: Nerve Damage
MAUDE report 12564103 ↗MalfunctionSep 22, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED AT C7 POST-OPERATIVELY. THE EVENT WAS NOTICED DURING A THREE MONTH FOLLOW-UP. THERE ARE NO PLANS FOR REVISION SURGERY THUS FAR. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED PYRENEES SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12515569 ↗MalfunctionSep 22, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED AT C7 POST-OPERATIVELY. THE EVENT WAS NOTICED DURING A THREE MONTH FOLLOW-UP. THERE ARE NO PLANS FOR REVISION SURGERY THUS FAR. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED PYRENEES SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12515567 ↗MalfunctionSep 22, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED AT C5 POST-OPERATIVELY. THE EVENT WAS NOTICED DURING A FOLLOW-UP. THERE ARE NO PLANS FOR REVISION SURGERY THUS FAR. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED PYRENEES SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12513191 ↗MalfunctionSep 22, 2021Fracture; Fracture
IT WAS REPORTED THAT TWO PYRENEES SELF-TAPPING SCREWS FRACTURED AT C5 POST-OPERATIVELY. THE EVENT WAS NOTICED DURING A FOLLOW-UP. THERE ARE NO PLANS FOR REVISION SURGERY THUS FAR. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED PYRENEES SELF-TAPPING SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12513145 ↗MalfunctionSep 3, 2021Fracture; Fracture
IT WAS REPORTED VIA XRAY, POST-OPERATIVELY, THAT A PYRENEES CONSTRAINED SELF TAPPING SCREW BROKE. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12425310 ↗
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
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- 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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