YUKON OCT Spinal System 7601-05028Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888857350014), received between Mar 18, 2020 and Dec 23, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A YUKON POLYAXIAL SCREW FRACTURED POST-OPERATIVELY AND THAT IT IS UNKNOWN IF A REVISION SURGERY WILL BE PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23882348 ↗
• InjuryOct 15, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY FOUR YEARS POST-OPERATIVELY TO ADDRESS TWO YUKON POLYAXIAL SCREW NECK FRACTURES. IT WAS FURTHER REPORTED THAT THE PATIENT WAS COMPLAINING. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 23301422 ↗
• InjuryOct 15, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23300214 ↗
• MalfunctionAug 7, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE NECK OF A YUKON POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED SCREW SHANK REMAINS IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741857 ↗
• InjuryMar 6, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED APPROXIMATELY THREE MONTHS POST-OPERATIVELY. THE PATIENT WILL BE REVISED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542867 ↗
• InjuryMar 6, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED APPROXIMATELY THREE MONTHS POST-OPERATIVELY. THE PATIENT WILL BE REVISED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542774 ↗
• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318102 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE HEAD OF A YUKON OCT POLYAXIAL SCREW FRACTURED FROM THE SHANK OF THE SCREW INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE SURGICAL DELAY AND WITH THE SCREW SHAFT REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345571 ↗
• InjuryMar 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO YUKON OCT POLYAXIAL SCREWS BROKE THREE WEEKS POST-OPERATIVELY. THE PATIENT IS REPORTED TO HAVE "FELT THE SCREWS DISLODGE" WHILE OPENING A HEAVY DOOR. REVISION HAS OCCURRED. THIS REPORT WILL REPRESENT THE SECOND OF TWO SCREWS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11555928 ↗
• MalfunctionApr 15, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  STRYKER REPRESENTATIVE REPORTED THAT THE HEAD OF A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW BROKE OFF WHEN THE SCREWDRIVER DETACHED FROM THE TULIP HEAD INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963817 ↗
• MalfunctionMar 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW HEAD FRACTURED INTRA-OPERATIVELY. AS THE SCREW WAS FULLY INSERTED, THE SHAFT WAS LEFT IN THE PATIENT AND SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849580 ↗