Navigated NIM-SPINE® 9733497Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169555495), received between Nov 20, 2020 and Sep 28, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) OPENED AND USED A NEW PRODUCT TO COMPLETE THE SURGERY. THE BROKEN PART DIDN¿T FALL IN THE PATIENT, THE INSTRUMENT WAS REMOVE FROM THE BONE AND THE HCP COULD SEE THAT THE PLASTIC PART WAS BROKEN BUT STILL ATTACHED. THEY REMOVED THE BROKEN PART FROM THE REST OF THE INSTRUMENT WHEN THE INSTRUMENT WAS ON THE INSTRUMENT TABLE. IT IS UNKNOWN HOW THE INSTRUMENT BROKE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539817 ↗
• MalfunctionJun 7, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PAK NEEDLE BROKE FROM THE FRAME DURING USE. THE NEEDLE WAS REMOVED WITHOUT INCIDENT. ANOTHER NEEDLE WAS OPENED AND USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946142 ↗
• MalfunctionNov 20, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE HANDLE OF NEEDLE BROKE OFF THE CANNULA WHILE BEING HAMMERED INTO PEDICLE OF LUMBAR SPINE. THERE WAS NO REPORTED HARM TO THE PATIENT PRESENT, AND THERE WAS A DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10879836 ↗