YUKON OCT Spinal System 7601-05030MRecalls & reported problems
VB Spine LLC · Polyaxial Screw ML Ø5.0x30 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 10888857351851), received between Oct 19, 2020 and Dec 8, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752509 ↗InjuryNov 29, 2023Fracture; Fracture
A PATIENT WAS REVISED TO ADDRESS YUKON POLYAXIAL SCREWS FRACTURED AT T2 BILATERALLY. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18233960 ↗InjuryNov 29, 2023Fracture; Fracture
A PATIENT WAS REVISED TO ADDRESS YUKON POLYAXIAL SCREWS FRACTURED AT T2 BILATERALLY. THIS REPORT WILL CAPTURE THE FIRST OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18233839 ↗MalfunctionNov 22, 2021Fracture; Fracture
IT WAS REPORTED THAT 2 YUKON POLYAXIAL SCREWS FRACTURED INTRA-OPERATIVELY DURING SCREW INSERTION. ALL THE FRACTURED PIECES WERE REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12857919 ↗MalfunctionOct 19, 2020Fracture; Fracture
IT WAS REPORTED THAT A YUKON POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. THE EVENT RESULTED IN A 20 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10696871 ↗
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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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