PYRENEES Cervical Plate System 201-90133Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888857030244), received between Jun 25, 2021 and Jul 29, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE PYRENEES NON-TAPERED DRIVER TIP DEFORMATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131873 ↗
• 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 FOURTH OF THE FIVE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992867 ↗
• MalfunctionApr 1, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A PYRENEES NON-TAPERED TORQUE DRIVER BROKE OFF IN THE SCREW INTRA-OPERATIVELY. THE TIP WAS RETRIEVED, ANOTHER DRIVER WAS USED, AND SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976468 ↗
• MalfunctionMar 30, 2022Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A PYRENEES NON-TAPERED TORQUE DRIVER WOULD NO LONGER GRIP THE SCREW HEAD INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRIVER AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957013 ↗
• MalfunctionMar 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A PYRENEES NON-TAPERED TORQUE DRIVER BROKE OFF INTRA-OPERATIVELY. THE FRACTURED PIECE WAS REMOVED FROM THE SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY BY USING AN ALTERNATIVELY AVAILABLE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13933040 ↗
• MalfunctionMar 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES CONSTRAINED CERVICAL NON-TAPERED DRIVERS STRIPPED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13734755 ↗
• MalfunctionMar 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES CONSTRAINED CERVICAL NON-TAPERED DRIVERS STRIPPED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FIRST OF TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13733429 ↗
• MalfunctionFeb 3, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT A PYRENEES SIZE 10 TAPERED DRIVER WOULD NOT HOLD THE SCREWS AND TWO PYRENEES SIZED 10 NON-TAPERED TORQUE DRIVERS HAD DEFORMED THREADING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE FIRST OF TWO PYRENEES SIZED 10 NON-TAPERED TORQUE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446898 ↗
• MalfunctionFeb 3, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT A PYRENEES SIZE 10 TAPERED DRIVER WOULD NOT HOLD THE SCREWS AND TWO PYRENEES SIZED 10 NON-TAPERED TORQUE DRIVERS HAD DEFORMED THREADING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO PYRENEES SIZED 10 NON-TAPERED TORQUE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446896 ↗
• MalfunctionJan 10, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES CONSTRAINED CERVICAL DRIVERS WERE STRIPPED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF THE TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206338 ↗
• MalfunctionJan 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES CONSTRAINED CERVICAL DRIVERS WERE STRIPPED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF THE TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206313 ↗
• MalfunctionDec 17, 2021Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT A PYRENEES CONSTRAINED CERVICAL TORQUE DRIVER WAS SLIPPING AT THE TIP INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026852 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  T WAS REPORTED THAT THE TIPS OF 2 PYRENEES NON-TAPERED TORQUE DRIVERS STRIPPED AND ANOTHER ONE BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FIRST OF TWO TIP DEFORMATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011577 ↗
• MalfunctionDec 15, 2021Fracture; Material Deformation; Fracture; Material Deformation

  T WAS REPORTED THAT THE TIPS OF 2 PYRENEES NON-TAPERED TORQUE DRIVERS STRIPPED AND ANOTHER ONE BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF TWO TIP DEFORMATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011560 ↗
• MalfunctionDec 15, 2021Fracture; Material Deformation; Fracture; Material Deformation

  T WAS REPORTED THAT THE TIPS OF 2 PYRENEES NON-TAPERED TORQUE DRIVERS STRIPPED AND ANOTHER ONE BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE FRACTURED DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011558 ↗
• MalfunctionDec 8, 2021Fracture; Fracture

  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 SECOND OF THE TWO PYRENEES NON-TAPERED TORQUE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962513 ↗
• MalfunctionDec 8, 2021Fracture; Fracture

  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 FIRST OF THE TWO PYRENEES NON-TAPERED TORQUE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962501 ↗
• MalfunctionNov 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE PYRENEES NON-TAPERED TORQUE DRIVER BROKE OFF INTO THE SCREW HEAD INTRA-OPERATIVELY, DURING FINAL TIGHTENING. THE FRACTURED COMPONENT WAS LEFT IN THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884073 ↗
• MalfunctionOct 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF PYRENEES TORQUE DRIVER STRIPPED INTRA-OPERATIVELY, DURING TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704491 ↗
• MalfunctionJun 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A PYRENEES DRIVER STRIPPED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071559 ↗