Navigated Spine Instruments 7601-N90003-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857514782), received between Jan 26, 2022 and Dec 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882053 ↗
• MalfunctionDec 23, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877174 ↗
• 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 A 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 15700822 ↗
• 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 ONE INSTANCE OF INTRAOPERATIVE YUKON SCREW INSERTER COUPLING ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO-MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135881 ↗
• 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 FOUR INSTANCES OF INTRAOPERATIVE YUKON NAVIGATED SCREW INSERTER TIP COUPLING ISSUES (JAMMING). IN ALL CASES, 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 14253240 ↗
• MalfunctionJan 26, 2022Mechanical Jam; Failure to Eject; Mechanical Jam; Failure to Eject

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIPS OF NAVIGATED YUKON OCT POLYAXIAL SCREW INSERTERS WERE STICKING WHEN TRYING TO DISENGAGE FROM THE SCREW. 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 13362048 ↗