YUKON OCT Spinal System 7601-04526Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888857349797), received between Dec 20, 2021 and Feb 26, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE NECK OF A YUKON POLYAXIAL SCREW FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24455577 ↗
• MalfunctionDec 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT A YUKON OCT POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY, THE SCREW WAS UNABLE TO BE REMOVED AND LEFT IN PEDICLE WITHOUT TULIP HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 45-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20997697 ↗
• MalfunctionDec 17, 2024Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20958934 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT ONE YUKON POLYAXIAL SCREW FRACTURED AT T2 AND ONE YUKON SET SCREW MIGRATED APPROXIMATELY 6 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE POLYAXIAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865231 ↗
• MalfunctionDec 6, 2024Fracture; Migration; Fracture; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT ONE YUKON POLYAXIAL SCREW FRACTURED AT T2 AND ONE YUKON SET SCREW MIGRATED APPROXIMATELY 6 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865204 ↗
• InjuryJun 27, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 2 MONTHS POST-OPERATIVELY TO ADDRESS A FRACTURED YUKON POLYAXIAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623791 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  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 YUKON POLYAXIAL SCREW FRACTURE. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATELY THIRTY-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SHAFT OF THE FRACTURED SCREW REMAINS IN THE PATIENT'S BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135614 ↗
• MalfunctionDec 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF A YUKON POLYAXIAL 'BROKE FROM BETWEEN HEAD AND PROXIMAL SHAFT' INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN HOUR DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043197 ↗