YUKON OCT Spinal System 7601-05032Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø5.0x32 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857350038), received between Oct 29, 2021 and Feb 19, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Neck Pain2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21414366 ↗MalfunctionFeb 19, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. THIS WAS IDENTIFIED IN POST-OPERATIVE IMAGING TAKEN APPROXIMATELY 15 MONTHS AFTER IMPLANTATION. THE SCREWS REMAIN IMPLANTED. THIS CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21414266 ↗InjuryApr 19, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS EXPERIENCING PAIN APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION AND UNDERWENT REVISION SURGERY TO ADDRESS MIGRATION OF A YUKON POLYAXIAL SCREW AT C2 AND DISCOVERED ANOTHER YUKON POLYAXIAL SCREW FRACTURE AT T2 INTRA-OPERATIVELY. THIS REPORT CAPTURES THE FIRST OF TWO YUKON POLYAXIAL SCREWS.
Patient problems: Neck Pain
MAUDE report 19143123 ↗InjuryApr 19, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT WAS EXPERIENCING PAIN APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION AND UNDERWENT REVISION SURGERY TO ADDRESS MIGRATION OF A YUKON POLYAXIAL SCREW AT C2 AND DISCOVERED ANOTHER YUKON POLYAXIAL SCREW FRACTURE AT T2 INTRA-OPERATIVELY. THIS REPORT CAPTURES THE SECOND OF TWO YUKON POLYAXIAL SCREWS.
Patient problems: Neck Pain
MAUDE report 19143120 ↗MalfunctionOct 29, 2021Fracture; Fracture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE A YUKON OCT POLYAXIAL SCREW BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12721727 ↗
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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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