YUKON OCT Spinal System 7601-04012-G1Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø4.0x12 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 10888857394483), received between Apr 14, 2022 and Apr 14, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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
- Migration4
Patient problems
- Pain4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE FOURTH OF FOUR YUKON POLYAXIAL SCREWS.
Patient problems: Pain
MAUDE report 14115625 ↗InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE THIRD OF FOUR YUKON POLYAXIAL SCREWS.
Patient problems: Pain
MAUDE report 14115566 ↗InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE FIRST OF FOUR YUKON POLYAXIAL SCREWS.
Patient problems: Pain
MAUDE report 14115451 ↗InjuryApr 14, 2022Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT FOUR YUKON POLYAXIAL SCREWS MIGRATED FROM C4 AND C5 AND THE YUKON SET SCREWS AT C2 DID NOT RETAIN THE RODS. THE PATIENT HAS REPORTED EXPERIENCING PAIN AND REVISION SURGERY IS SCHEDULED. THIS REPORT CAPTURES THE SECOND OF FOUR YUKON POLYAXIAL SCREWS.
Patient problems: Pain
MAUDE report 14115444 ↗
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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