Navigated NIM-SPINE® Pedicle Access System Kit 9733497Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994475152), received between Nov 2, 2016 and Nov 2, 2016 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A MINIMALLY INVASIVE SPINE PROCEDURE, THE SURGEON ALLEGED BEING UNABLE TO TRACK THEIR PEDICLE ACCESS KIT (PAK) NEEDLE BECAUSE IT WAS TOO FAR DOWN INTO THE PATIENT. THE SURGEON FOUND THE PAK NEEDLE COULD NOT BE TRACKED AT THE ANGLE HE WAS USING. THE SURGEON PLACED A SCREW TOO LATERALLY IN L3, PERFORMED ANOTHER SPIN AND REPOSITIONED THE SCREW. THE PAK NEEDLE NEVER MALFUNCTIONED, RATHER IT WAS NOT LONG ENOUGH FOR WHAT THE SURGEON DESIRED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION. DELAY IN THERAPY WAS LESS THAN ONE HOUR. REPORT NOTED TO BE A FEATURE REQUEST. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S PAK NAVIGATED SPINE PEDICLE NEEDLE. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: Iatrogenic Source; Spinal Column Injury

  MAUDE report 6073969 ↗