YUKON OCT Spinal System 7601-04030Recalls & reported problems
VB Spine LLC · Polyaxial Screw Ø4.0x30 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 10888857349605), received between Aug 2, 2019 and Jul 28, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Fracture; Fracture
THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE MAIN BODY OF A YUKON OCT POLYAXIAL SCREW BROKE DURING INSERTION. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30-60 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12242671 ↗MalfunctionApr 14, 2020Fracture; Fracture
IT WAS REPORTED THAT A YUKON OCT SPINAL SYSTEM POLYAXIAL SCREW FRACTURED INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30-MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9960332 ↗MalfunctionAug 2, 2019Fracture; Fracture; Material Separation
IT WAS REPORTED THAT DURING IMPLANT INSERTION, THE YUKON POLYAXIAL SCREW HEAD "SHEARED COMPLETELY OFF" WHERE IT MEETS THE TULIP. 2/3 OF THE SCREW SHANK REMAINED IN THE PATIENT. AN ATTEMPT TO REMOVE THE SCREW RESULTED IN A 20 MINUTE DELAY. NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT IS REPORTED TO BE "DOING WELL." THE SURGEON WAS ABLE TO OBTAIN GOOD FIXATION AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8857067 ↗
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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