YUKON OCT Spinal System 7601-05034Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø5.0x34 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857350045), received between Nov 10, 2020 and Nov 6, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Neck Pain2
- Pain2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT AN YUKON POLYAXIAL SCREW FRACTURED AT THE SCREW/TULIP INTERFACE DURING INSERTION. THE SHANK OF THE SCREW WAS RETAINED AT T2 PEDICLE ON THE RIGHT MAKING IT NECESSARY TO EXTEND THE CONSTRUCT TO T3 TO PROVIDE ADEQUATE POINTS OF CONSTRUCT FIXATION. THE PROCEDURE WAS COMPLETED WITH ONE HOUR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18080142 ↗MalfunctionApr 28, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS AT T1 FRACTURED POST-OPERATIVELY. THE PATIENT REPORTED EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT PLANNED. THIS REPORT CAPTURES THE SECOND OF TWO FRACTURED SCREWS.
Patient problems: Neck Pain; Pain
MAUDE report 16837661 ↗MalfunctionApr 28, 2023Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT TWO YUKON POLYAXIAL SCREWS AT T1 FRACTURED POST-OPERATIVELY. THE PATIENT REPORTED EXPERIENCING NECK PAIN. REVISION SURGERY IS NOT PLANNED. THIS REPORT CAPTURES THE FIRST OF TWO FRACTURED SCREWS.
Patient problems: Neck Pain; Pain
MAUDE report 16837647 ↗MalfunctionOct 29, 2021Fracture; Fracture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE A YUKON OCT POLYAXIAL SCREW BROKE 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 12723258 ↗MalfunctionNov 10, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A YUKON OCT POLYAXIAL SCREW TULIP DISENGAGED INTRA-OPERATIVELY. DURING SCREW INSERTION, THE SCREW HEAD KEPT SPINNING AND THE SCREW WOULD NOT ADVANCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH A 15 MINUTE SURGICAL DELAY, BY REPLACING THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10818086 ↗
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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