YUKON OCT Spinal System 7601-05024Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888857349995), received between Jun 26, 2020 and Dec 4, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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.

• InjuryDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO YUKON POLYAXIAL SCREWS THAT FRACTURED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE FIRST OF TWO YUKON POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846664 ↗
• InjuryDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO YUKON POLYAXIAL SCREWS THAT FRACTURED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF TWO YUKON POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846521 ↗
• 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 FIRST OF TWO SCREWS.

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

  MAUDE report 11555925 ↗
• MalfunctionMar 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT 2 YUKON OCT POLYAXIAL SCREWS AT T1 BROKE POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490064 ↗
• MalfunctionMar 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT 2 YUKON OCT POLYAXIAL SCREWS AT T1 BROKE POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489952 ↗
• MalfunctionDec 8, 2020Nonstandard Device; Nonstandard Device

  A STRYKER SALES REPRESENTATIVE IDENTIFIED AN INCORRECTLY MARKED YUKON POLYAXIAL SCREW DURING RESTOCK OF A CONSIGNMENT SET TRAY, OUTSIDE THE OPERATING THEATER. THE SUBJECT SCREW WAS INCORRECTLY LASER MARKED WITH SIZE Ø5.0 (DIAMETER) & 24 (MM LENGTH) WITH CATALOG NUMBER 7601-05024. HOWEVER, THE SCREW SHOULD HAVE BEEN MARKED Ø4.0 (DIAMETER) & 26 (MM LENGTH) WITH ASSOCIATED CATALOG NUMBER 7601-04026. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE NO ADVERSE CONSEQUENCE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969239 ↗
• InjurySep 23, 2020Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE SCREW INSERTION INTO THE T1 PEDICLE A YUKON POLYAXIAL SCREW FRACTURED AT THE SHAFT. THE SCREW SHAFT COULD NOT BE REMOVED AND REMAINS AT THAT LEVEL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5-10 MINUTE SURGICAL DELAY BY BYPASSING THAT LEVEL AND PROCEEDING ON WITH THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10574761 ↗
• MalfunctionJun 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW BROKE OFF OF THE SHANK DURING INSERTION INTO THE PEDICLE OF T2. THE SCREW WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203370 ↗