YUKON OCT Spinal System 7601-03512Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø3.5x12 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857349308), received between Feb 7, 2023 and Jun 11, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Migration; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS THE MIGRATION OF TWO YUKON SET SCREWS AND ONE YUKON POLYAXIAL SCREW APPROXIMATELY SIX WEEKS AFTER IMPLANTATION. THIS RECORD CAPTURES A YUKON POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19516173 ↗InjuryJun 7, 2024Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS THE MIGRATION OF ONE YUKON POLYAXIAL SCREW AND ONE YUKON SET SCREW. THIS REPORT CAPTURES THE YUKON POLYAXIAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488588 ↗MalfunctionFeb 7, 2023Fracture; Fracture
IT WAS REPORTED THAT A FRAGMENT OF A YUKON POLYAXIAL SCREW FRACTURED OFF INTRA-OPERATIVELY. THE SCREW AND THE BROKEN PIECE WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THE EVENT WAS INITIALLY REPORTED TO STRYKER VIA IN MEDWATCH (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16314868 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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