YUKON OCT Spinal System 7601-90001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857343948), received between Nov 12, 2020 and Nov 12, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (7 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 3, 2020Class IITerminated

   Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

   Z-0520-2021 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833139 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833081 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833075 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10833065 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10832996 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10832913 ↗
• MalfunctionNov 12, 2020Nonstandard Device; Nonstandard Device

  DURING DEVICE INSPECTION, IT WAS NOTED THAT A YUKON ANTI-TORQUE ALIGNMENT TUBE WAS OUT OF SPECIFICATION. WHEN TESTED, THE FINAL TIGHTENING SHAFT WOULD NOT PROPERLY MATE WITH THE ANTI-TORQUE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10832862 ↗