PYRENEES Cervical Plate System 201-90118Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888857030183), received between Oct 27, 2015 and Jul 29, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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 17 most recent of 17 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 SIX INSTANCES OF INTRAOPERATIVE PYRENEES TAPERED DRIVER TIP DEFORMATION. IN TWO (OF SIX) INSTANCES, THE REPORTED EVENT WAS NOTED DURING INSPECTION AND THERE WAS NO PROCEDURE ASSOCIATED WITH THE EVENT AND NO PATIENT INVOLVEMENT. IN FOUR (OF SIX) THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN ALL CASES, THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133038 ↗
• 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 FIRST OF THE FIVE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992801 ↗
• 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 FIFTH OF THE FIVE DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992759 ↗
• MalfunctionFeb 3, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  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 PYRENEES SIZE 10 TAPERED DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446897 ↗
• MalfunctionDec 28, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES SCREWDRIVERS SHOWED SIGNS OF WEAR AND TEAR, AFTER A PROCEDURE. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED PYRENEES SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101037 ↗
• MalfunctionDec 28, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES SCREWDRIVERS SHOWED SIGNS OF WEAR AND TEAR, AFTER A PROCEDURE. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD CAPTURES THE FIRST OF THE TWO REPORTED PYRENEES SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13100904 ↗
• MalfunctionDec 22, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE TIP OF A PYRENEES TAPERED DRIVER IS WORN AND NOT HOLDING THE SCREWS OUTSIDE OF THE OR. 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 13061914 ↗
• MalfunctionDec 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT "WEAR AND TEAR" WAS OBSERVED ON THE TIPS OF 2 PYRENEES TAPERED DRIVERS POST-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 12961172 ↗
• MalfunctionDec 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT "WEAR AND TEAR" WAS OBSERVED ON THE TIPS OF 2 PYRENEES TAPERED DRIVERS POST-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 12961148 ↗
• MalfunctionNov 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE PYRENEES TAPERED DRIVER BROKE DURING SCREW INSERTION INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844943 ↗
• MalfunctionAug 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES TAPERED DRIVERS SHOWED SIGNS OF WEAR AND TEAR OUTSIDE THE OPERATING ROOM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF TWO SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304794 ↗
• MalfunctionAug 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIPS OF TWO PYRENEES TAPERED DRIVERS SHOWED SIGNS OF WEAR AND TEAR OUTSIDE THE OPERATING ROOM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF TWO SCREWDRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304756 ↗
• MalfunctionAug 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PYRENEES CONSTRAINED CERVICAL TAPERED DRIVER TIP STRIPPED OUT INTRA-OPERATIVELY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.  THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260317 ↗
• MalfunctionJun 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 2- PYRENEES TAPERED DRIVER TIPS WERE STRIPPED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL 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 12094565 ↗
• MalfunctionJun 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 2- PYRENEES TAPERED DRIVER TIPS WERE STRIPPED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO DRIVERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094526 ↗
• MalfunctionJun 15, 2016Break; Break

  IT WAS REPORTED TO K2M, INC ON 6/2/2016 THAT ON (B)(6) 2016 A DRIVER TIP SHEARED OFF IN THE SCREW HEAD INTRA-OP AND WAS LEFT IN THE SCREW.

  Patient problems: No Information

  MAUDE report 5725493 ↗
• MalfunctionOct 27, 2015Break

  IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A SURGERY TOOK PLACE IN WHICH A TAPERED DRIVER TIP SHEARED OFF INTO THE SCREW HEAD. THE SURGERY TOOK PLACE (B)(6) 2015.

  Patient problems: No Information

  MAUDE report 5180923 ↗