YUKON OCT Spinal System 7601-05026Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888857350007), received between Aug 30, 2019 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.

• InjuryDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS. IT WAS FURTHER REPORTED THAT THE FRACTURES WERE OBSERVED ON A 6-MONTH POST-OPERATIVE X-RAY. A PORTION OF THE SCREWS WERE EXPLANTED, HOWEVER THE FRACTURED SCREW SHANKS REMAINED IN THE PATIENT AND LOWER LEVELS WERE THEN FUSED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: Back pain; Insufficient Information

  MAUDE report 23877176 ↗
• InjuryDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS. IT WAS FURTHER REPORTED THAT THE FRACTURES WERE OBSERVED ON A 6-MONTH POST-OPERATIVE X-RAY. A PORTION OF THE SCREWS WERE EXPLANTED, HOWEVER THE FRACTURED SCREW SHANKS REMAINED IN THE PATIENT AND LOWER LEVELS WERE THEN FUSED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: Back pain; Insufficient Information

  MAUDE report 23877175 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY AND THAT A REVISION SURGERY WILL BE PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 23843437 ↗
• MalfunctionDec 18, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY AND THAT IT IS UNKNOWN IF A REVISION SURGERY WILL BE PERFORMED. THE DEVICES REMAIN IMPLANTED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 23843248 ↗
• InjuryApr 23, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO YUKON OCT POLYAXIAL SCREWS THAT FRACTURED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: Pain

  MAUDE report 21896600 ↗
• InjuryApr 23, 2025Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO YUKON OCT POLYAXIAL SCREWS THAT FRACTURED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: Pain

  MAUDE report 21896598 ↗
• MalfunctionOct 30, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF 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 WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697630 ↗
• InjuryOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS ONE FRACTURED YUKON POLYAXIAL SCREW AT C5 AND ONE FRACTURED YUKON POLYAXIAL SCREW AT C7. IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPERIENCING PAIN. THIS REPORT CAPTURES THE FIRST OF THE TWO FRACTURED SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15596152 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q2 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 WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135739 ↗
• MalfunctionNov 8, 2019Fracture; Break; Fracture

  PHYSICIAN REPORTED THAT WHILE PERFORMING A C1-T1 FUSION, THE HEAD BROKE OFF OF A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW; SIZE 05.0X26MM IN THE LEFT T1 INTRA-OPERATIVELY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. SURGERY WAS COMPLETED WITH A 15 MINUTE DELAY AND A NEW SCREW OF THE SAME SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298343 ↗
• MalfunctionAug 30, 2019Break; Break

  A PHYSICIAN REPORTED THAT A SHAFT OF A YUKON SCREW BROKE DURING IMPLANT SURGERY. THE DEVICE WAS REMOVED AND REPLACED WITH A 30 MINUTE DELAY; SURGERY WAS COMPLETED WITH A BACK-UP DEVICE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8950233 ↗