YUKON OCT Spinal System 7601-04528Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø4.5x28 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
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888857349803), received between Aug 11, 2020 and Feb 26, 2026 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 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
- Fracture10
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Fracture
MalfunctionNov 6, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION SURGERY HAS NOT TAKEN PLACE NOR BEEN SCHEDULED AND NO ADVERSE CONSEQUENCES WERE REPORTED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493162 ↗MalfunctionNov 6, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23493160 ↗InjurySep 9, 2025Fracture; Fracture
THE PATIENT WAS REVISED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23000077 ↗InjurySep 9, 2025Fracture; Fracture
THE PATIENT WAS REVISED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23000076 ↗MalfunctionFeb 15, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A YUKON POLYAXIAL SCREW FRACTURED JUST BELOW THE TULIP INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16378912 ↗MalfunctionJun 14, 2022Fracture; Fracture
IT WAS REPORTED THAT A YUKON POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691404 ↗MalfunctionOct 29, 2021Fracture; Fracture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE DURING SCREW INSERTION INTO THE PEDICLE, A YUKON OCT POLYAXIAL SCREW BROKE ALONG THE SCREW'S SHANK. THE THREADED SHANK WAS REMOVED AND A NEW SCREW WAS INSERTED. 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 12720972 ↗MalfunctionJun 4, 2021Fracture; Fracture
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A YUKON SCREW BROKE INTRA-OPERATIVELY DURING INSERTION AT T2. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11941613 ↗MalfunctionAug 11, 2020Fracture; Fracture
IT WAS REPORTED THAT A YUKON OCT POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. THE SCREW SHANK BROKE UNDERNEATH THE TULIP HEAD WHILE THE SURGEON WAS INSERTING THE YUKON SCREW INTO THE PRE-TAPPED PEDICLE AT T1. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT AND THE EVENT RESULTED IN A 10-15 MINUTE SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10391876 ↗
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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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