PYRENEES® Cervical Plate System 208-42F42Recalls & reported problems
VB Spine LLC · Constrained Plate, 2 Level Size 42 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857030961), received between Jun 17, 2016 and Sep 24, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture4
Patient problems
- Pain2
- Convulsion/Seizure1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Shaking/Tremors1
- Unspecified Immune System Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2021Fracture; Fracture
A PATIENT REPORTED UNDERGOING REVISION SURGERY TO EXPLANT A FRACTURED PYRENEES PLATE. THE PLATE WAS IMPLANTED IN 2013 AND THE DEVICE WAS NOTED TO BE FRACTURED APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION. THE PATIENT REPORTS THAT IN 2014 THEY EXPERIENCED PAIN AS WELL AS, "19K WHITE BLOOD COUNT, TREMORS, SEIZURES, AND SO FORTH." IN 2015 THE DEVICE WAS EXPLANTED. THE PATIENT REPORTS THEY ARE LEFT WITH, "LONG TERM DAMAGE THAT WILL CONTINUE PROGRESSIVELY."
Patient problems: Convulsion/Seizure; Pain; Shaking/Tremors; Unspecified Immune System Problem
MAUDE report 12529994 ↗MalfunctionMar 1, 2021Fracture; Fracture
A PHYSICIAN REPORTED A PYRENEES CONSTRAINED TWO-LEVEL PLATE FRACTURED APPROXIMATELY TWO-YEARS AFTER IMPLANTATION. THE DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11396804 ↗MalfunctionNov 25, 2019Fracture; Fracture
A PHYSICIAN REPORTED THAT A PYRENEES PLATE FRACTURED APPROXIMATELY 4 TO 6 MONTHS AFTER IMPLANTATION. THE PHYSICIAN IS NOT PLANNING REVISION SURGERY AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9372927 ↗MalfunctionJun 17, 2016Fracture; Fracture
IT WAS REPORTED TO K2M INC ON (B)(6) 2016 THAT A PLATE FRACTURED APPROXIMATELY 6 MONTHS POST-OPERATIVELY.
Patient problems: Pain
MAUDE report 5731896 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- 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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