NA 286755001NRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034472225), received between Dec 17, 2019 and Jul 15, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 15, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE THE SCRUB TECH WAS TRANSFERRING THE INSTRUMENT TO THE BACK TABLE, THE DRIVER FELL TO THE FLOOR WITH AN IMPACT TO THE SURETRAK ARRAY. THE IMPACT CAUSED THE THREADED PORTION OF THE NAV ADAPTER TO STRIP/PULL OUT. THE DAMAGE WAS DUE TO AN ACCIDENTAL DROP, AND THE PATIENT WAS NOT IMPACTED AS THE PART OF THE PROCEDURE THAT USES THE TOOL HAD BEEN COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A UNIVERSAL NAVIGATION ADAPTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15030761 ↗
• MalfunctionOct 29, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE NAVIGATION ADAPTORS BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY. THIS REPORT IS FOR ONE (1) UNIVERSAL NAVIGATION ADAPTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757301 ↗
• MalfunctionOct 29, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE NAVIGATION ADAPTORS BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY. THIS REPORT IS FOR ONE (1) UNIVERSAL NAVIGATION ADAPTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10757226 ↗
• MalfunctionJan 7, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2019, THE UNIVERSAL ADAPTOR BROKE OFF WHEN THE HEALTH CARE PROFESSIONAL REMOVED THE SURETRAK. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS COMPLAINT IS FOR ONE (1) UNAV ADAPTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558774 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE UNIVERSAL ADAPTOR FOR THE MEDTRONIC BROKE. THE SCREW HOLE WAS STRIPPED OUT WHEN PUTTING THE INSTRUMENTS TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE UNIVERSAL NAVIGATION ADAPTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481156 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE UNIVERSAL ADAPTOR FOR THE MEDTRONIC BROKE. THE SCREW HOLE WAS STRIPPED OUT WHEN PUTTING THE INSTRUMENTS TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE UNIVERSAL NAVIGATION ADAPTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481126 ↗