YUKON OCT Spinal System 7601-04024MRecalls & reported problems
VB Spine LLC · Polyaxial Screw ML Ø4.0x24 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857350410), received between Oct 29, 2021 and Sep 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A YUKON POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED COMPONENT REMAINED IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190461 ↗MalfunctionOct 29, 2021Fracture; Fracture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE DURING INSERTION, THE SHAFT OF A YUKON SCREW BROKE. IT WAS FURTHER REPORTED THAT THE THE DISTAL PORTION WAS NOT ABLE TO BE REMOVED FROM THE BONE. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12720859 ↗
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- 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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