YUKON OCT Spinal System 7601-04530Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø4.5x30 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857349810), received between Nov 25, 2019 and Jan 28, 2021 — classified as 4 injuries, 1 malfunction.
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.
Most reported problems
Device problems
- Fracture5
- Appropriate Device Problem Term/Code Not Available2
- Break2
Patient problems
- Injury4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2021Fracture; Fracture
THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE YUKON OCT POLYAXIAL SCREWS FRACTURED 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 11247991 ↗InjuryMar 11, 2020Fracture; Fracture
PHYSICIAN REPORTED THAT 2 YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS; SIZE Ø4.5X30 MM FRACTURED AT THE NECK OF THE SHAFT POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: Injury
MAUDE report 9821386 ↗InjuryMar 11, 2020Fracture; Fracture
PHYSICIAN REPORTED THAT 2 YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS; SIZE Ø4.5X30 MM FRACTURED AT THE NECK OF THE SHAFT POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Injury
MAUDE report 9821385 ↗InjuryNov 25, 2019Fracture; Break; Fracture; Appropriate Device Problem Term/Code Not Available
PHYSICIAN REPORTED THAT TWO YUKON OCT POLYAXIAL SCREWS, SIZE 04.5X30MM, BROKE AT THE SHAFT POST-OPERATIVELY. REVISION SURGERY WILL BE PERFORMED. THIS REPORT REPRESENTS THE SECOND OF TWO POLYAXIAL SCREWS.
Patient problems: Injury
MAUDE report 9371084 ↗InjuryNov 25, 2019Fracture; Break; Fracture; Appropriate Device Problem Term/Code Not Available
PHYSICIAN REPORTED THAT TWO YUKON OCT POLYAXIAL SCREWS, SIZE 04.5X30MM, BROKE AT THE SHAFT POST-OPERATIVELY. REVISION SURGERY WILL BE PERFORMED. THIS REPORT REPRESENTS THE FIRST OF TWO POLYAXIAL SCREWS.
Patient problems: Injury
MAUDE report 9371081 ↗
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- 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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