PYRENEES Cervical Plate SystemRecalls & reported problems across all models
VB Spine LLC · 29 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 96
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 29 models of PYRENEES Cervical Plate System by VB Spine LLC in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2015 and Feb 20, 2026 — classified as 23 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Fracture” (38 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PYRENEES Cervical Plate System problems
Device problems
- Fracture38
- Material Deformation34
- Break10
- Migration8
- Naturally Worn5
- Migration or Expulsion of Device4
- Insufficient Device Problem Information3
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Information15
- Pain8
- Injury5
- Device Embedded In Tissue or Plaque3
- Nerve Damage2
- Convulsion/Seizure1
- No Code Available1
PYRENEES Cervical Plate System models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PYRENEES Cervical Plate System 201-90133Orthopedic manual surgical instrument20 reports
- PYRENEES Cervical Plate System 201-90118Orthopedic manual surgical instrument17 reports
- PYRENEES® Cervical Plate System 201-14016CAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY10 reports
- PYRENEES® Cervical Plate System 201-14014DAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6 reports
- PYRENEES® Cervical Plate System 201-14016DAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY5 reports
- PYRENEES® Cervical Plate System 208-42F42APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- PYRENEES® Cervical Plate System 208-43F60APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- PYRENEES® Cervical Plate System 201-14012DAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 201-14014CAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES Cervical Plate System 201-90030Orthopedic manual surgical instrument2 reports
- PYRENEES Cervical Plate System 201-90140Orthopedic manual surgical instrument2 reports
- PYRENEES® Cervical Plate System 208-42F40APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 208-42F44APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 208-43F51APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 208-43F54APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 208-43F57APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- PYRENEES® Cervical Plate System 201-14018CAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES Cervical Plate System 201-90070Orthopedic manual surgical instrument1 report
- PYRENEES® Cervical Plate System 201-90176APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 208-42F38APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 208-43F63APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 208-44F69APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 208-44F73APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 208-44F85APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 5901-14512DAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 5901-14514CAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 6801-13514CAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 6801-13514DAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- PYRENEES® Cervical Plate System 6808-90027ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent PYRENEES Cervical Plate System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408109 ↗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 ↗MalfunctionDec 10, 2024Fracture; Fracture
IT WAS REPORTED THAT A PYRENEES 4 LEVEL CONSTRAINED PLATE AT C5 FRACTURED FOUR MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20896295 ↗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 ↗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 ↗InjuryApr 26, 2023Fracture; Fracture
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 FRACTURED PLATE.
Patient problems: Pain
MAUDE report 16820696 ↗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 ↗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 SECOND OF THE TWO MIGRATED SCREWS.
Patient problems: Pain
MAUDE report 16820692 ↗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 ↗InjurySep 30, 2022Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO PYRENEES SELF-STARTING SCREWS WHICH HAD MIGRATED OUT OF A PYRENEES PLATE APPROXIMATELY THIRTEEN MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE FIRST OF THE TWO MIGRATED SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15513184 ↗InjurySep 30, 2022Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO PYRENEES SELF-STARTING SCREWS WHICH HAD MIGRATED OUT OF A PYRENEES PLATE APPROXIMATELY THIRTEEN MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE SECOND OF THE TWO MIGRATED SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15513106 ↗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 SIX INSTANCES OF INTRAOPERATIVE PYRENEES TAPERED DRIVER TIP DEFORMATION. IN TWO (OF SIX) INSTANCES, THE REPORTED EVENT WAS NOTED DURING INSPECTION AND THERE WAS NO PROCEDURE ASSOCIATED WITH THE EVENT AND NO PATIENT INVOLVEMENT. IN FOUR (OF SIX) THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN ALL CASES, THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15133038 ↗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 PYRENEES NON-TAPERED DRIVER TIP DEFORMATION. THE 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 15131873 ↗
Other VB Spine LLC products
- EVEREST Spinal System77 models · 336 reports · 3 recalls
- YUKON OCT Spinal System54 models · 238 reports · 3 recalls
- OZARK Cervical Plate System54 models · 270 reports
- MESA Spinal System55 models · 140 reports
- ALEUTIAN Interbody Systems37 models · 135 reports
- CHESAPEAKE Stabilization System31 models · 46 reports · 1 recall
- DENALI Spinal System22 models · 80 reports
- CASCADIA Interbody System28 models · 65 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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