YUKON OCT Spinal System 7601-05030M-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857395831), received between Oct 29, 2021 and Nov 17, 2022 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2022Fracture; Migration; Fracture; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 14 MONTHS AFTER IMPLANTATION TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS AT T1 AND ONE MIGRATED YUKON SET SCREW. THIS REPORT IS FOR THE SECOND OF TWO FRACTURED YUKON POLYAXIAL SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821849 ↗
• InjuryNov 17, 2022Fracture; Migration; Fracture; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 8 MONTHS AFTER IMPLANTATION TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS AT T1, ONE OF WHICH ALSO MIGRATED AND ONE MIGRATED YUKON SET SCREW. THIS REPORT IS FOR THE SECOND OF TWO FRACTURED YUKON POLYAXIAL SCREWS. THIS SCREW ALSO MIGRATED AT T1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815864 ↗
• InjuryNov 17, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 3 MONTHS AFTER IMPLANTATION TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS AT T1. THIS REPORT IS FOR THE SECOND SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815682 ↗
• InjurySep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST-OPERATIVELY A YUKON OCT POLYAXIAL SCREW SHANK FRACTURED AT THE TULIP HEAD AND SHANK JUNCTION AT T1. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396559 ↗
• InjurySep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 11- 14 MONTHS POST-OPERATIVELY A YUKON OCT POLYAXIAL SCREW SHANK FRACTURED AT THE TULIP HEAD AND SHANK JUNCTION AT T1. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396543 ↗
• InjurySep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST-OPERATIVELY A YUKON OCT POLYAXIAL SCREW SHANK FRACTURED AT THE TULIP HEAD AND SHANK JUNCTION AT T1. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396451 ↗
• MalfunctionOct 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE A YUKON OCT POLYAXIAL SCREW BROKE WHILE BEING REDIRECTED INTO A NEW PATH. THE SCREW SHAFT WAS RETRIEVED AND SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREW AND A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721080 ↗