PYRENEES Cervical Plate System 201-90030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857029873), received between Jul 12, 2022 and Jul 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2022Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT FOUR PYRENEES CONSTRAINED CERVICAL DRIVERS WERE NOT HOLDING SCREWS AND ONE PYRENEES CONSTRAINED CERVICAL TORQUE LIMITING DRIVER DID NOT FIT PROPERLY IN HANDLE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF THE FIVE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993021 ↗
• MalfunctionJul 12, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT FOUR PYRENEES CONSTRAINED CERVICAL DRIVERS WERE NOT HOLDING SCREWS AND ONE PYRENEES CONSTRAINED CERVICAL TORQUE LIMITING DRIVER DID NOT FIT PROPERLY IN HANDLE INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE THIRD OF THE FIVE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993014 ↗