YUKON OCT Spinal System 7601-03516Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø3.5x16 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857349322), received between May 21, 2022 and Mar 11, 2025 — classified as 3 injuries.
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
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21579217 ↗InjuryNov 17, 2022Fracture; Fracture
A PATIENT WAS REVISED TO ADDRESS A FRACTURED YUKON POLYAXIAL SCREW AT C5 (RIGHT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15815860 ↗InjuryMay 21, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST-OPERATIVELY, REVISION SURGERY WAS PERFORMED TO ADDRESS AN UNKNOWN MISPOSITIONED SCREW. DURING THIS PROCEDURE IT WAS DISCOVERED THAT THE HEAD OF A YUKON SCREW COULD NOT BE MOVED. THE YUKON SCREW WAS THEN REMOVED WHICH CAUSED DAMAGE TO THE MASSA LATERALIS. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 4 MINUTE SURGICAL DELAY. THIS REPORT CAPTURES THE YUKON SCREW.
Patient problems: Bone Fracture(s)
MAUDE report 14464937 ↗
Other Orthosis, cervical pedicle screw spinal fixation devices
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- CONNECTOR 79-2002Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- CONNECTOR 79-2003Orthofix US LLC · Posterior cervical screw system1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Medtronic Sofamor Danek, Inc. · Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- OASYS 48551000Stryker Corporation · Orthosis, cervical pedicle screw spinal fixation45 reports
- SYMPHONY 1020-35-112Medos International Sàrl · Posterior cervical screw system6 deaths15 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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