YUKON OCT Spinal System 7601-04540Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø4.5x40 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857349865), received between May 20, 2022 and Jun 16, 2022 — classified as 3 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.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS HEADS BROKE OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14713777 ↗MalfunctionJun 16, 2022Fracture; Fracture
IT WAS REPORTED THAT TWO YUKON OCT SPINAL SYSTEM POLYAXIAL SCREWS HEADS BROKE OFF INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14713776 ↗MalfunctionMay 20, 2022Break
WHILE IMPLANTING TWO SEPARATE 4.5X30MM SCREWS INTO PATIENTS BACK THE SCREW HEADS BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 14456522 ↗
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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