YUKON OCT Spinal System 7601-10001Recalls & reported problems
VB Spine LLC · Set Screw · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a VB Spine Yukon spinal interlaminar fixation set screw, an implant used to hold spinal hardware in place during surgery. The 61 reports mostly describe set screws that shift out of position after implantation, with some loosening, dislodgment, and audible noise; several patients needed revision surgery, and one had four screws migrate while being treated for neck pain. Reports mention 34 injuries and 27 malfunctions, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10888857328310), received between Sep 4, 2019 and Jan 22, 2026 — classified as 33 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Migration” (55 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration55
- Migration or Expulsion of Device6
- Device Dislodged or Dislocated5
- Loosening of Implant Not Related to Bone-Ingrowth4
- Adverse Event Without Identified Device or Use Problem3
- Ambient Noise Problem2
- Noise, Audible2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient16
- Injury13
- No Code Available5
- Pain5
- Neck Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Migration
A COMPANY REPRESENTATIVE REPORTED THAT A YUKON SET SCREW MIGRATED APPROXIMATELY THREE WEEKS POST-OPERATIVELY. AT THIS TIME, REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED.
Patient problems: Insufficient Information
MAUDE report 24150574 ↗InjuryDec 9, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 23764423 ↗InjuryDec 9, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 23764421 ↗InjuryJun 6, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH NECK PAIN WAS REVISED TO ADDRESS FOUR MIGRATED YUKON SET SCREWS. THIS REPORT CAPTURES THE FIRST OF FOUR YUKON SET SCREWS.
Patient problems: Neck Pain
MAUDE report 22161997 ↗InjuryJun 6, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH NECK PAIN WAS REVISED TO ADDRESS FOUR MIGRATED YUKON SET SCREWS. THIS REPORT CAPTURES THE THIRD OF FOUR YUKON SET SCREWS.
Patient problems: Neck Pain
MAUDE report 22161996 ↗InjuryJun 6, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH NECK PAIN WAS REVISED TO ADDRESS FOUR MIGRATED YUKON SET SCREWS. THIS REPORT CAPTURES THE SECOND OF FOUR YUKON SET SCREWS.
Patient problems: Neck Pain
MAUDE report 22161991 ↗InjuryJun 6, 2025Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WITH NECK PAIN WAS REVISED TO ADDRESS FOUR MIGRATED YUKON SET SCREWS. THIS REPORT CAPTURES THE FOURTH OF FOUR YUKON SET SCREWS.
Patient problems: Neck Pain
MAUDE report 22160996 ↗InjurySep 27, 2024Material Erosion; Migration; Material Erosion; Migration
IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS TWO YUKON SET SCREWS THAT MIGRATED POST-OPERATIVELY. THIS REPORT IS FOR THE SECOND OF TWO YUKON SET SCREWS.
Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions
MAUDE report 20317940 ↗InjuryJun 12, 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 THE SECOND OF TWO YUKON SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520346 ↗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 THE FIRST OF TWO YUKON SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19516156 ↗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 SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19482696 ↗InjuryMay 16, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT IS SCHEDULED FOR REVISION SURGERY TO ADDRESS THE MIGRATION OF TWO YUKON SET SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED YUKON SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337523 ↗InjuryMay 16, 2024Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT IS SCHEDULED FOR REVISION SURGERY TO ADDRESS THE MIGRATION OF TWO YUKON SET SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO MIGRATED YUKON SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337434 ↗InjuryJun 9, 2023Migration; Migration
IT WAS REPORTED VIA MW 5117345 THAT TWO YUKON POLYAXIAL SCREWS AT T1 FRACTURED AND TWO YUKON SET SCREWS AT THAT SAME LEVEL MIGRATED POST-OPERATIVELY. THE PATIENT REPORTEDLY EXPERIENCED "CHRONIC PAIN" AND WAS REVISED. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED SET SCREWS.
Patient problems: Pain
MAUDE report 17100967 ↗MalfunctionApr 18, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON SET SCREWS AT T1 MIGRATED APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766081 ↗MalfunctionApr 18, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON SET SCREWS AT T1 MIGRATED APPROXIMATELY TWO-MONTHS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766079 ↗InjuryNov 17, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 8 MONTHS AFTER IMPLANTATION TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS AT T1, ONE OF WHICH ALSO MIGRATED AND ONE MIGRATED YUKON SET SCREW. THIS REPORT IS FOR THE YUKON SET SCREW WHICH MIGRATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15815886 ↗InjuryNov 17, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 14 MONTHS AFTER IMPLANTATION TO ADDRESS TWO FRACTURED YUKON POLYAXIAL SCREWS AT T1 AND ONE MIGRATED YUKON SET SCREW. THIS REPORT IS FOR THE MIGRATED YUKON SET SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15815715 ↗InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE FIRST OF TWO YUKON SET SCREWS.
Patient problems: Pain
MAUDE report 14115658 ↗InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE SECOND OF TWO YUKON SET SCREWS.
Patient problems: Pain
MAUDE report 14115657 ↗MalfunctionMar 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A YUKON BLOCKER AT THE TOP OF THE CONSTRUCT HAS MIGRATED POST-OPERATIVELY. REVISION WILL NOT OCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13639944 ↗MalfunctionJul 30, 2021Migration; Migration
IT WAS REPORTED THAT TWO YUKON SET SCREWS AT C6 MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF THE TWO SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252561 ↗MalfunctionJul 30, 2021Migration; Migration
IT WAS REPORTED THAT TWO YUKON SET SCREWS AT C6 MIGRATED POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF THE TWO SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252557 ↗MalfunctionMar 11, 2021Ambient Noise Problem; Noise, Audible; Migration; Ambient Noise Problem; Noise, Audible; Migration
IT WAS REPORTED THAT A PATIENT HAS BEEN "COMPLAINING OF SQUEAKY NOISE IN NECK" POST-OPERATIVELY. XRAY PROVIDED SHOWS A LOOSE YUKON OCT SET SCREW AT T2. REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467554 ↗MalfunctionMar 11, 2021Ambient Noise Problem; Noise, Audible; Ambient Noise Problem; Noise, Audible
IT WAS REPORTED THAT A PATIENT WAS 'COMPLAINING OF SQUEAKY NOISE IN NECK' POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE NATURE OF THE REPORTED NOISE IS UNKNOWN AT THIS TIME AND NO RELATIONSHIP TO THE DEVICES HAS BEEN ESTABLISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467520 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- 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
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page