NIM-SPINE 9733498NAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169345171), received between Dec 27, 2016 and Nov 4, 2020 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE TO ADDRESS STENOSIS. IT WAS REPORTED THAT A CANNULA BROKE AND FRAGMENTED INTO RIGHT L4. ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE POSTERIOR PORTION OF THE CANNULA. THERE WAS NO PATIENT HARM AND THE PROCEDURE DELAY WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10785697 ↗
• MalfunctionOct 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE 2 NEEDLES WERE DAMAGED. ONE NEEDLE BROKE INSIDE THE PATIENT AND PIECES HAD TO BE REMOVED FROM INSIDE THE PINE WITH DIFFICULTY. THE PATIENT WAS REQUIRED TO BE CONVERTED TO AN OPEN PROCEDURE FROM A MINIMALLY INVASIVE ONE. A PART OF THE NEEDLE WAS LEFT INSIDE THE PATIENT BECAUSE THE SURGEON DETERMINED THAT IT WOULD CAUSE MORE HARM ATTEMPTING TO RETRIEVE THE BROKEN ITEM. THE PROCEDURE FINISHED SUCCESSFULLY. THREE NEEDLES WERE USED ON THE CASE. ONE BROKE, ONE BENT AND THE OTHER WORKED AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174990 ↗
• InjuryOct 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING PROCEDURE 2 NEEDLES WERE DAMAGED. ONE NEEDLE BROKE INSIDE THE PATIENT AND PIECES HAD TO BE REMOVED FROM INSIDE THE PINE WITH DIFFICULTY. THE PATIENT WAS REQUIRED TO BE CONVERTED TO AN OPEN PROCEDURE FROM A MINIMALLY INVASIVE ONE. A PART OF THE NEEDLE WAS LEFT INSIDE THE PATIENT BECAUSE THE SURGEON DETERMINED THAT IT WOULD CAUSE MORE HARM ATTEMPTING TO RETRIEVE THE BROKEN ITEM. THE PROCEDURE FINISHED SUCCESSFULLY. THREE NEEDLES WERE USED ON THE CASE. ONE BROKE, ONE BENT AND THE OTHER WORKED AS INTENDED.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 9174895 ↗
• MalfunctionDec 27, 2016Break; Break

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE INSTRUMENT BROKE OFF IN THE LEFT L5 PEDICLE. THE SURGEON EVENTUALLY REMOVED THE PIECE OF INSTRUMENT. THEY CONFIRMED WITH X-RAY THAT ALL OF THE INSTRUMENT WAS COMPLETELY REMOVED FROM PATIENT. THIS CAUSED A 45 MINUTE DELAY IN PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM AND THE BACKUP INSTRUMENT FROM THE KIT . THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED. IT WAS REPORTED THAT THE PATIENT'S BONE WAS VERY OSTEOPOROTIC AND MORE SUSCEPTIBLE TO THE NEEDLE BECOMING STUCK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6206475 ↗