PYRENEES® Cervical Plate System 201-14014DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857026995), received between Jul 6, 2017 and Sep 30, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO PYRENEES SELF-STARTING SCREWS WHICH HAD MIGRATED OUT OF A PYRENEES PLATE APPROXIMATELY THIRTEEN MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE FIRST OF THE TWO MIGRATED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513184 ↗
• InjurySep 30, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO PYRENEES SELF-STARTING SCREWS WHICH HAD MIGRATED OUT OF A PYRENEES PLATE APPROXIMATELY THIRTEEN MONTHS AFTER IMPLANTATION. THIS REPORT CAPTURES THE SECOND OF THE TWO MIGRATED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513106 ↗
• InjuryDec 5, 2019Fracture; Fracture

  AFTER AN X-RAY DISCOVERED THREE BROKEN PYRENEES SELF-STARTING SCREWS, A PATIENT UNDERWENT REVISION SURGERY. THIS REPORT WILL CAPTURE THE THIRD OF THE THREE SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9419496 ↗
• InjuryDec 5, 2019Fracture; Fracture

  AFTER AN X-RAY DISCOVERED THREE BROKEN PYRENEES SELF-STARTING SCREWS, A PATIENT UNDERWENT REVISION SURGERY. THIS REPORT WILL CAPTURE THE SECOND OF THE THREE SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9419491 ↗
• InjuryDec 5, 2019Fracture; Fracture

  AFTER AN X-RAY DISCOVERED THREE BROKEN PYRENEES SELF-STARTING SCREWS, A PATIENT UNDERWENT REVISION SURGERY. THIS REPORT WILL CAPTURE THE FIRST OF THE THREE SCREWS.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9419488 ↗
• InjuryJul 6, 2017Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE CERVICAL SCREW BACK-OUT. THE PATIENT REPORTEDLY HAD A POSSIBLE CERVICAL SCREW BACK-OUT APPROXIMATELY 2 WEEKS POST-OP. THE PATIENT WAS NOT REVISED. ON (B)(6) 2017 K2M, INC. WAS NOTIFIED THAT THE PATIENT WAS REVISED DUE TO THE RISK OF THE SCREW POSSIBLY BACKING-OUT FURTHER.

  Patient problems: No Information

  MAUDE report 6688888 ↗