YUKON OCT Spinal System 7601-90138Recalls & reported problems
VB Spine LLC · Torque Limiting Handle Size 2.2N-m · Class 1
All models of YUKON OCT Spinal System (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857384194), received between Jun 11, 2024 and Jun 11, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Calibration Problem” (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
- Calibration Problem2
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2024Calibration Problem; Insufficient Device Problem Information; Calibration Problem; Insufficient Device Problem Information
TWO YUKON TORQUE LIMITING HANDLES WHICH WERE USED IN TWO IMPLANT SURGERIES WHICH RESULTED IN IMPLANT MIGRATION REQUIRE FUNCTIONAL AND CALIBRATION CHECKS. THIS REPORT CAPTURES THE SECOND OF TWO TORQUE LIMITING HANDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509661 ↗InjuryJun 11, 2024Calibration Problem; Insufficient Device Problem Information; Calibration Problem; Insufficient Device Problem Information
TWO YUKON TORQUE LIMITING HANDLES WHICH WERE USED IN TWO IMPLANT SURGERIES WHICH RESULTED IN IMPLANT MIGRATION REQUIRE FUNCTIONAL AND CALIBRATION CHECKS. THIS REPORT CAPTURES THE FIRST OF TWO TORQUE LIMITING HANDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509659 ↗
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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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