YUKON OCT Spinal System 7601-05024MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857351820), received between Apr 29, 2021 and Oct 30, 2022 — classified as 2 malfunctions.

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.

• MalfunctionOct 30, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE YUKON POLYAXIAL SCREW FRACTURE. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697449 ↗
• MalfunctionApr 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE SCREW HEADS OF TWO YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS "SHEARED OFF" AT T1 AND T2 INTRA-OPERATIVELY. ALL DEBRIS WAS REMOVED, THE SCREWS WERE REPLACED, AND SURGERY WAS SUCCESSFULLY COMPLETED WITH A 20-30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747899 ↗