Navigation Instruments 7601-N90003-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888857415973), received between Mar 9, 2021 and Dec 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (6 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854805 ↗
• MalfunctionJan 30, 2023Mechanical Jam; Failure to Eject; Mechanical Jam; Failure to Eject

  THIS RECORD IS A CONSOLIDATION OF Q4 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE YUKON NAVIGATED SCREW INSERTER JAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265214 ↗
• MalfunctionOct 31, 2022Failure to Eject; Failure to Eject

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCE OF INTRAOPERATIVE YUKON NAVIGATED SCREW INSERTER JAMMING IN WHICH THE PHYSICIAN HAD DIFFICULTY DISSOCIATING THE TIP OF THE INSERTER FROM THE SCREW AFTER SCREW INSERTION. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700536 ↗
• MalfunctionJul 29, 2022Failure to Eject; Failure to Eject

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES FOUR INSTANCES OF INTRAOPERATIVE YUKON NAVIGATED SCREW INSERTER COUPLING ISSUES. IN ALL INSTANCES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135949 ↗
• MalfunctionApr 29, 2022Failure to Eject; Failure to Eject

  THIS RECORD IS A CONSOLIDATION OF Q1 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE YUKON SCREW INSERTER TIP COUPLING ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FOUR-MINUTE DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255018 ↗
• MalfunctionJan 26, 2022Mechanical Jam; Failure to Eject; Mechanical Jam; Failure to Eject

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIPS OF NAVIGATED CERVICAL YUKON POLYAXIAL SCREW INSERTERS WERE STICKING WHEN TRYING TO DISENGAGE FROM THE SCREW. SURGERIES WERE SUCCESSFULLY COMPLETED. ONE EVENT EXPERIENCED AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361907 ↗
• MalfunctionOct 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS WHERE THE TIPS OF NAVIGATED YUKON OCT POLYAXIAL SCREW INSERTERS WERE STICKING IN THE SCREW HEAD INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721320 ↗
• MalfunctionJul 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE TIP OF A NAVIGATED YUKON OCT POLYAXIAL SCREW INSERTER WAS STICKING IN THE SCREW HEADS 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 12245888 ↗
• MalfunctionApr 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS WHERE THE TIP OF AN YUKON OCT POLYAXIAL SCREW INSERTER GOT "STUCK IN SCREWS" INTRA-OPERATIVELY. A FIVE MINUTE DELAY WAS REPORTED IN ONE PROCEDURE. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745381 ↗
• MalfunctionMar 9, 2021Mechanical Jam; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT A YUKON NAVIGATED SCREW INSERTER TIP WAS JAMMING DURING SURGERY AND COULD NOT BE DISCONNECTED FROM THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY FOLLOWING AN UNSPECIFIED DELAY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446072 ↗