NA 3010-19-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034561448), received between Sep 30, 2022 and Sep 17, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that during a procedure on (b)(6) 2026, during screw insertion into the sacrum, the device in question was used under navigation guidance to prepare a pilot hole. After the tap had been advanced approximately 50 mm, the surgeon noticed an abnormality and stated that the tactile resistance had suddenly been lost. The tap was carefully withdrawn, and it was observed that the threaded tip portion had fractured and separated from the device. The surgery was completed successfully, and there was no surgical delay. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808504 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING POSTERIOR SPINAL FUSION, A NAV TAP BROKE OFF IN PEDICLE. NO FRAGMENTS IN THE PATIENT BODY. A REMOVAL INSTRUMENT WAS USED TO RETRIEVED THE BROKEN PORTION. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 90 MINUTES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 5MM NAV DUAL LEAD CAN TAP. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514687 ↗