PYRENEES® Cervical Plate System 208-43F54Recalls & reported problems
VB Spine LLC · Constrained Plate, 3 Level Size 54 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857031159), received between Jan 12, 2017 and Mar 26, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation
IT WAS REPORTED THAT DURING INTRA-OPERATIVE SCREW INSERTION, A PYRENEES CONSTRAINED CERVICAL PLATE WAS UNABLE TO LOCK AND CAPTURE THE FOUR PYRENEES CONSTRAINED CERVICAL SELF-TAPPING SCREWS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY TO SURGERY BY USING AN ALTERNATIVELY AVAILABLE PLATE AND SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11575156 ↗InjuryJan 12, 2017Break; Break
ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BROKEN 3 LEVEL PLATE. THE PATIENT REPORTEDLY HAD A 3 LEVEL PLATE BREAK APPROXIMATELY 7 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME AS THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Information
MAUDE report 6246271 ↗
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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