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 ↗
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- 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
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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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