YUKON OCT Spinal System 7601-04018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857349544), received between Jul 30, 2021 and Oct 13, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS ONE FRACTURED YUKON POLYAXIAL SCREW AT C5 AND ONE FRACTURED YUKON POLYAXIAL SCREW AT C7. IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPERIENCING PAIN. THIS REPORT CAPTURES THE SECOND OF THE TWO FRACTURED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15596124 ↗
• MalfunctionJul 30, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE A YUKON POLYAXIAL SCREW FRACTURED DURING INSERTION. THE SURGEON OPTED TO LEAVE THE SHAFT OF THE SCREW IN THE PATIENT AS THEY FELT IT WOULD BE MORE DETRIMENTAL TO ATTEMPT REMOVAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254964 ↗