PYRENEES Cervical Plate System 201-90140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857030299), received between Dec 8, 2021 and Dec 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (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

Recent adverse event reports

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

• MalfunctionDec 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PYRENEES TORQUE LIMITING HANDLE WAS OBSERVED TO BE CRACKED DURING INSPECTION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112578 ↗
• MalfunctionDec 8, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT TWO PYRENEES NON-TAPERED TORQUE DRIVERS BROKE, AND THE PYRENEES TORQUE LIMITING HANDLE WAS SUSPECTED TO BE OUT OF CALIBRATION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES OCCURRED. THIS RECORD CAPTURES THE PYRENEES TORQUE LIMITING HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962575 ↗