N/A 9734680Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00613994870063), received between Dec 9, 2016 and Apr 30, 2026 — classified as 2 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (35 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD EXTREMELY HARD BONE. THE SURGEON BROKE OFF THE TIP OF THE THORACIC PROBE AS HE WAS REMOVING THE INSTRUMENT IT FROM THE PEDICLE. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE TIP WAS REMOVED FROM THE BONE. IT WAS NOTED THAT IT TOOK PROBABLY 30-45 MINUTES TO REMOVE THE BROKEN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050461 ↗
• MalfunctionJan 22, 2025Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS TWISTED. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON THE PATIENT'S OUTCOME. THE LIKELY CAUSE WAS HARD BONE SUBSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210030 ↗
• MalfunctionDec 27, 2024Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE PROBE WAS BENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026035 ↗
• MalfunctionSep 17, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS BENT DURING NORMAL USE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237358 ↗
• MalfunctionAug 16, 2023Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED IN A SACROILIAC AND THORACOLUMBAR. IT WAS REPORTED THAT THE PROBE WAS SLIGHTLY BENT AT THE TIP. THE SURGEON WAS STILL ABLE TO VERIFY THE PROBE. NO IMPACT ON PATIENT OUTCOME. THE EXTENDED SURGICAL TIME WAS LESS THAN 1 HOUR. THE SUSPECTED CAUSE OF THE ISSUE WAS A HARD CORTICAL BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560745 ↗
• MalfunctionOct 7, 2022Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PROBE WAS BROKE AT L5. THE BONE WAS INCREDIBLY HARD AND HAD TO MALLET THE NAVIGATED PROBE INTO THE PEDICLE AND IT GOT WEDGED IN. THE HEALTH CARE PROFESSIONAL ATTEMPTED TO BACK SLAP AND TWIST AND THE INSTRUMENT SIMPLY WOULDN¿T COME OUT. UNFORTUNATELY, THE TIP BROKE OFF IN THE PATIENT AND COULD NOT BE RETRIEVED. THERE WAS NO DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563384 ↗
• MalfunctionMay 5, 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 STATED THAT THE NAVIGATED THORACIC PROBE WAS BENT AND CONTINUED TO USE THE INSTRUMENT. NOTHING HAPPENED TO THE PATIENT. THE SURGERY WENT ON AS PLANNED, MERELY NOTING THAT THE PROBE WAS BENT. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DAMAGED WAS SUSPECTED TO HAVE BEEN CAUSED BY CONTINUOUS USE OF THE PROBE IN ATTEMPTS TO PENETRATE CORTICAL BONE, SUBSEQUENTLY BENDING THE TIP AND NORMAL WEAR-AND-TEAR. IT WAS NOTED THAT THE PROBE WAS UNLIKELY TO HAVE BEEN DAMAGED PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776196 ↗
• MalfunctionSep 15, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA//PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE PROBE BROKEN OFF INSIDE THE PEDICLE (40MM). THE MANUFACTURING REPRESENTATIVE REPORTS THAT THE SURGEON WAS MALLETING THE PROBE AND THE TIP BROKE OFF. THE INSTRUMENT BROKE DURING THE PLACEMENT OF 3 OUT OF THE 4 SCREWS. 2 SCREWS WERE PLACED ALREADY ON THE LEFT SIDE, SO THE SURGEON DECIDED TO DO A UNILATERAL FUSION. THE SURGEON WAS UNABLE TO REMOVE THE PIECE OF THE PROBE AND WAS LEFT IN THE RIGHT L4 PEDICLE. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10538177 ↗
• MalfunctionMar 27, 2020Material Integrity Problem; Material Integrity Problem

  ON 2020-MAR-25 (B)(4) (HCP, REP, FOR); MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE STRAIGHT THORACIC PROBE WAS REPORTED TO HAVE BEEN DEFECTIVE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9888426 ↗
• MalfunctionMar 10, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE THORACIC PROBE BENT INSTANTLY WHEN PRESSURE WAS APPLIED. THE PROBE WAS NOT USED ANY LONGER AT THAT POINT. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OR A NON-NAVIGATED PROBE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813868 ↗
• MalfunctionFeb 20, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS DEFORMED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9733545 ↗
• MalfunctionDec 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THE TIP OF THE THORACIC PROBE WAS DEFORMED. IT WAS NOTED THE THORACIC PROBE WAS NOT USED FOR THIS PROCEDURE AS THE CERVICAL PROBE WAS USED. THIS ISSUE WAS NOTED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9474856 ↗
• MalfunctionDec 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS A DAMAGED NAVLOCK AND THORACIC PROBE. THE THORACIC PROBE WAS STUCK IN THE ORANGE NAVLOCK. IT WAS UNCLEAR WHICH INSTRUMENT WAS DAMAGED AND CAUSING THE ISSUE. THE WINGS WOULD NOT RELEASE. IT HAD BEEN DETERMINED THAT THE THORACIC PROBE AND ORANGE NAVLOCK COULD NOT BE SEPARATED EASILY BY THE PERSONNEL. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9447724 ↗
• MalfunctionOct 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A CAUSE OR CONTRIBUTING FACTOR TO THE PROBE BECOMING BENT WAS THE BONE WAS CONCRETE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING NAVIGATION AND ANOTHER INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255786 ↗
• MalfunctionOct 21, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PROBE HAD A DAMAGED TIP. THE REPRESENTATIVE DID NOT KNOW IF THE DEVICE COULD BE VERIFIED OR NOT. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213889 ↗
• MalfunctionSep 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR. IT WAS REPORTED THAT THE NAVLOCK WAS UNABLE TO BE REMOVED FROM THE PROBE. IT WAS ALSO REPORTED THAT THE TIP OF THE PROBE WAS BENT. THE DAMAGE WAS NOT DISCOVERED UNTIL AFTER THE SURGERY. THERE WAS NO REPORTED DELAY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9117584 ↗
• MalfunctionAug 29, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THE TIP OF THE THORACIC PROBE WAS BENT. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8945836 ↗
• MalfunctionJul 31, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE NAVLOCK THORACIC PROBE WAS DEFORMED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8846973 ↗
• MalfunctionJun 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE NAVLOCK THORACIC PROBE WAS BENT. THE PROCEDURE WAS COMPLETE WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8727185 ↗
• MalfunctionJun 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS BENT. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8717568 ↗
• MalfunctionJun 16, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT PROBE WAS ROTATED AT THE TIP. ISSUE RESOLVED WITH PART REPLACEMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 8702447 ↗
• MalfunctionMay 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE WAS DAMAGED WHILE IN STERILE PROCESSING. THERE WAS NO PATIENT WHEN THE ISSUE OCCURRED."

  Patient problems: No Patient Involvement

  MAUDE report 8626194 ↗
• MalfunctionMay 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THORACIC PROBE HAD BEEN DAMAGED DURING USE. THE PATIENT HAD VERY HARD BONE AND THE TIP WAS FOUND TWISTED AFTER USE. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579345 ↗
• MalfunctionApr 15, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT BEFORE A PROCEDURE THE PROBE HAD DIFFICULTY ATTACHING TO THE TRACKER. THE MANUFACTURER REPRESENTATIVE SWAPPED OUT THE TRACKERS AND SAW THAT THE SAME BEHAVIOR WITH EACH TRACKER/PROBE COMBINATION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8513510 ↗
• MalfunctionApr 8, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SPINE PROCEDURE ON (B)(6), THE THORACIC PROBE WAS BENT, THE END TWISTED FROM USE OF THE PROBE WITH A MALLET. THERE WAS NO IMPACT TO THE PATIENT AND NO DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8491511 ↗