YUKON OCT Spinal System 7601-03514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857349315), received between Aug 2, 2019 and Jan 2, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  A PATIENT EXPERIENCED MIGRATION OF A C7 YUKON SET SCREW APPROXIMATELY TWO MONTHS AFTER IMPLANTATION. REVISION SURGERY IS NOT CURRENTLY PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428103 ↗
• MalfunctionDec 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED THEIR INITIAL SURGERY ON (B)(6) 2020 WHERE THEY RECEIVED A POSTERIOR CERVICAL FIXATION / FUSION. THE PATIENT THEN PRESENTED WITH CONSISTENT MYELOPATHY AMONG OTHER PAIN COMPLAINTS IN THEIR CERVICAL AREA. AN EXTENSION OF THE POSTERIOR CERVICAL LATERAL MASS FUSION AS WELL LAMINECTOMY WAS THEN PERFORMED IN (B)(6) 2021. DURING THE PLANNED REVISION SURGERY, THE YUKON SCREW AT C5 WHICH WAS ORIGINALLY IMPLANTED IN (B)(6) 2020 WAS NOTICED TO BE FRACTURED DURING REMOVAL. HALF OF THE SHAFT ATTACHED TO THE SCREW HEAD WAS ABLE TO BE REMOVED WHILE THE OTHER HALF REMAINS IN THE PATIENT. WELL ESTABLISHED BONE FUSION WAS NOTED ON THE REMAINING IMPLANTED SCREWS.

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

  MAUDE report 13047668 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem

  A YUKON SCREW INSERTER "STUCK" TO THE SCREW WHILE INSERTING AT THE RIGHT C3, CAUSING THE SURGEON TO APPLY ADDITIONAL FORCE. THIS FORCE BROKE THROUGH THE LATERAL MASS WHICH MADE IT ESSENTIAL TO EXTEND THE CONSTRUCT UP TO THE RIGHT C2 RESULTING IN A 10 MINUTE SURGICAL DELAY. THIS RECORD CAPTURES THE POLYAXIAL SCREW . IT WAS DETERMINED THAT THE YUKON OCT POLYAXIAL SCREW HAD NO CAUSE TO THE ADVERSE EVENT AND THAT THE DEVICE DID NOT MALFUNCTION. THEREFORE, THIS DEVICE IS A CONCOMITANT PRODUCT.

  Patient problems: Injury

  MAUDE report 9169098 ↗
• MalfunctionAug 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPANY REPRESENTATIVE REPORTED THAT THE SCREW SITE PREPARATION, THE YUKON POLYAXIAL SCREW Ø3.5X14 MM WAS "DIFFICULT TO LOAD SECURELY THE INSERT DRIVER" THE EVENT WAS NOTED DURING A CASE PREPARATION; THERE WAS NO PATIENT INVOLVEMENT. THE CASE WAS SUCCESSFULLY EXECUTED USING ALTERNATIVE SCREWS THAT WERE READILY AVAILABLE TO THE PHYSICIAN. THERE WAS NO HARM TO THE PATIENT AS THE EVENT WAS IDENTIFIED PREOPERATIVELY.

  Patient problems: No Information

  MAUDE report 8950626 ↗
• InjuryAug 2, 2019Migration; Migration; Physical Resistance/Sticking

  A PHYSICIAN REPORTED THAT A YUKON POLYAXIAL SCREW BECAME ¿STUCK¿ AT THE HEAD POSTOPERATIVELY. FOLLOWING IMPLANT SURGERY, THE PATIENT DID NOT WEAR THEIR CERVICAL COLLAR AS DIRECTED BY THE PHYSICIAN AND, ¿WENT BACK TO REGULAR ACTIVITIES BEFORE THEY WERE ADVISED TO.¿ THE PATIENT WAS REVISED AND LAMINA SCREWS C3 THROUGH C6 WERE REPLACED. PATIENT WAS REVISED AND ALL LAMINA SCREWS C3-C6 WERE REPLACED.

  Patient problems: Injury

  MAUDE report 8857535 ↗