YUKON OCT Spinal System 7601-90003Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888857352605), received between Oct 8, 2019 and Oct 29, 2022 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 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 TWELVE INSTANCE OF INTRAOPERATIVE YUKON SCREW INSERTER COUPLING ISSUES (JAMMING). THE ASSOCIATED PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694628 ↗
• 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 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 15135848 ↗
• 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 THREE INSTANCES OF INTRAOPERATIVE YUKON 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 14252895 ↗
• MalfunctionJan 27, 2022Mechanical Jam; Failure to Eject; Mechanical Jam; Failure to Eject

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS WHERE THE TIPS OF A YUKON SCREW INSERTERS WERE STICKING IN SCREW HEADS INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED, ONE WITH A 3 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13370601 ↗
• MalfunctionOct 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIPS OF YUKON OCT SCREW INSERTER JAMMED INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED; ONE PROCEDURE EXPERIENCED A 20 SECOND DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721197 ↗
• MalfunctionJul 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIPS OF YUKON OCT POLYAXIAL SCREW INSERTERS GOT "STUCK IN THE SCREW HEAD" INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSERTER AND NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247658 ↗
• MalfunctionApr 29, 2021Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE TIP OF A YUKON OCT POLYAXIAL SCREW INSERTER JAMMED DURING DEVICE INSPECTION PRE-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745385 ↗
• MalfunctionJul 31, 2020Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS WHERE THE TIP OF A YUKON SCREW INSERTER WAS JAMMING UPON DISENGAGEMENT FROM THE SCREW HEAD INTRA-OPERATIVELY. IN TWO (2) OF THE THREE (3) EVENTS, THERE WAS A SURGICAL DELAY OF 15-20 MINUTES. THE THIRD EVENT HAD AN UNKNOWN DELAY TIME. SURGERIES WERE SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES TO THE PATIENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10351330 ↗
• MalfunctionJan 30, 2020Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS, WHERE THE TIP OF A YUKON SCREW INSERTER WAS JAMMING UPON DISENGAGEMENT FROM THE SCREW HEAD INTRA-OPERATIVELY. IN ALL 4 EVENTS, THERE WAS A SURGICAL DELAY OF 30 SECONDS TO 5 MINUTES. SURGERIES WERE SUCCESSFULLY COMPLETED AND NO ADVERSE CONSEQUENCES TO THE PATIENTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649862 ↗
• MalfunctionNov 8, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF A YUKON SCREW INSERTER WAS JAMMING UPON DISENGAGEMENT FROM THE SCREW HEAD INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297618 ↗
• MalfunctionNov 8, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE TIP OF A YUKON SCREW INSERTER WAS JAMMING UPON DISENGAGEMENT FROM THE SCREW HEAD INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9296448 ↗
• MalfunctionOct 30, 2019Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS, WHERE THE TIP OF A YUKON SCREW INSERTER WAS JAMMING UPON DISENGAGEMENT FROM THE SCREW HEAD INTRA-OPERATIVELY. IN 8 OF THE 10 EVENTS, THERE WAS A SURGICAL DELAY OF 2-5 MINUTES, SURGERIES WERE SUCCESSFULLY COMPLETED, AND NO ADVERSE CONSEQUENCES TO THE PATIENTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257533 ↗
• InjuryOct 8, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam

  A YUKON SCREW INSERTER "STUCK" TO THE SCREW WHILE INSERTING AT THE RIGHT C3, CAUSING THE SURGEON TO APPLY ADDITIONAL FORCE. THIS FORCE BROKE THROUGH THE LATERAL MASS WHICH MADE IT ESSENTIAL TO EXTEND THE CONSTRUCT UP TO THE RIGHT C2 RESULTING IN A 10 MINUTE SURGICAL DELAY. THIS RECORD CAPTURES THE SCREW INSERTER.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9169100 ↗