PYRENEES® Cervical Plate System 201-14012DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857026957), received between Mar 4, 2022 and Mar 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionMar 4, 2022Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  A COMPANY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF A PYRENEES SYSTEM, THE PHYSICIAN HAD DIFFICULTY SECURING THE SCREWS. A ONE-LEVEL CONSTRAINED PYRENEES PLATE WAS PLACED AND THE TWO SUPERIOR PYRENEES SELF-STARTING SCREWS WOULD NOT ENGAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO PYRENEES SELF-STARTING SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673437 ↗
• MalfunctionMar 4, 2022Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  A COMPANY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF A PYRENEES SYSTEM, THE PHYSICIAN HAD DIFFICULTY SECURING THE SCREWS. A ONE-LEVEL CONSTRAINED PYRENEES PLATE WAS PLACED AND THE TWO SUPERIOR PYRENEES SELF-STARTING SCREWS WOULD NOT ENGAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO PYRENEES SELF-STARTING SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13673268 ↗