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YUKON OCT Spinal System 7601-03526Recalls & reported problems

VB Spine LLC · Polyaxial Screw Ø3.5x26 mm · Class 2 · Implant

All models of YUKON OCT Spinal System (54)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857349377), received between Feb 28, 2020 and Apr 2, 2021 — classified as 4 injuries.

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

Device problems

  • Insufficient Device Problem Information2
  • Mechanical Jam2
  • Fracture1
  • Migration1

Patient problems

  • Injury2
  • Insufficient Information2
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 2, 2021Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

    A COMPANY REPRESENTATIVE REPORTED THAT, DURING REMOVAL, TWO YUKON POLYAXIAL SCREWS, "HAD LOCKED IN PLACE SO IT WAS IMPOSSIBLE TO REMOVE WITH A DRIVER" AND THAT, "IT WAS LIKE THE HEAD WAS GOING TO COME OFF OF THE SCREW SHANK." THE REASON FOR DEVICE REMOVAL HAS NOT BEEN PROVIDED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11609556 ↗
  • InjuryApr 2, 2021Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

    A COMPANY REPRESENTATIVE REPORTED THAT, DURING REMOVAL, TWO YUKON POLYAXIAL SCREWS, "HAD LOCKED IN PLACE SO IT WAS IMPOSSIBLE TO REMOVE WITH A DRIVER" AND THAT, "IT WAS LIKE THE HEAD WAS GOING TO COME OFF OF THE SCREW SHANK." THE REASON FOR DEVICE REMOVAL HAS NOT BEEN PROVIDED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11609553 ↗
  • InjuryApr 21, 2020Migration; Migration

    PHYSICIAN REPORTED A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW; SIZE Ø3.5X26 MM PULL OUT AT C2 POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED.

    Patient problems: Injury

    MAUDE report 9981262 ↗
  • InjuryFeb 28, 2020Fracture; Fracture

    STRYKER REPRESENTATIVE REPORTED THAT A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW; SIZE Ø3.5X26 MM FRACTURED 1-3 MONTHS POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED.

    Patient problems: Injury

    MAUDE report 9770929 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources and updates

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