YUKON OCT Spinal System 7601-05030Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888857350021), received between Jul 17, 2019 and Jul 10, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470502 ↗
• MalfunctionDec 8, 2023Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT DURING ROUTINE POST-OPERATIVE FOLLOW-UP, IT WAS DISCOVERED THAT ONE OF THE YUKON OCT POLYAXIAL SCREWS FRACTURED AT T1 APPROXIMATELY THREE MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT CURRENTLY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297560 ↗
• MalfunctionNov 9, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP HEAD OF A YUKON OCT POLYAXIAL SCREW DETACHED FROM THE SCREW SHANK INTRA-OPERATIVELY. THE BROKEN SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER A 30-MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759744 ↗
• MalfunctionOct 29, 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 ONE INSTANCE OF INTRAOPERATIVE YUKON POLYAXIAL SCREW FRACTURE. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE FRACTURED SCREW. THERE WAS A 30-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695227 ↗
• MalfunctionJul 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE YUKON OCT POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH A 15 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247668 ↗
• MalfunctionJan 28, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS WHERE YUKON OCT POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247964 ↗
• MalfunctionOct 30, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT WHERE A YUKON OCT POLYAXIAL SCREW BROKE UPON INSERTION INTO THE T1 PEDICLE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREW AND A FIVE MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10764756 ↗
• MalfunctionOct 29, 2020Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A YUKON POLYAXIAL SCREW TULIP DISENGAGED POST-OPERATIVELY AT T1. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756871 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  A PHYSICIAN REPORTED A FRACTURED YUKON POLYAXIAL SCREW POST-OPERATIVELY. THE PATIENT HAS REPORTED "HEARING A CLICKING NOISE PERIODICALLY." REVISION SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701606 ↗
• MalfunctionOct 8, 2020Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT TWO YUKON SCREW TULIPS DISENGAGED APPROXIMATELY SIX MONTHS AFTER IMPLANTATION. REVISION STATUS IS CURRENTLY UNKNOWN. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10648759 ↗
• MalfunctionMar 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT 2 YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS FRACTURED 6 WEEKS POST-OPERATIVELY. THE DEVICE REMAINS IMPLANTED. THIS RECORD REPRESENTS SCREW 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9891845 ↗
• MalfunctionMar 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT 2 YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS FRACTURED 6 WEEKS POST-OPERATIVELY. THE DEVICE REMAINS IMPLANTED. THIS RECORD REPRESENTS SCREW 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9891796 ↗
• MalfunctionMar 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY DURING INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN SURGICAL DELAY USING A REPLACEMENT SCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875046 ↗
• InjurySep 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED THAT THE SHAFT OF A YUKON POLYAXIAL SCREW BROKE DURING IMPLANT SURGERY. THE BROKEN DEVICE WAS REMOVED AND REPLACED WITH A 15 MINUTE SURGICAL DELAY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8977600 ↗
• InjuryJul 17, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT THE POLYAXIAL SCREW BROKE POST OPERATIVELY; PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 8798310 ↗