N/A 9734678Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994870049), received between Oct 12, 2018 and Jun 2, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2022Use 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 DEFORMED. 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 14572765 ↗
• MalfunctionNov 24, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRIOR TO A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE AWL TIP AND THORACIC PROBE WERE DIFFICULT TO CONNECT TO THE INSTRUMENT TRACKER. THE CAUSE OF THE ISSUE WAS DEFORMATION, AND THE CAUSE OF THE DEFORMATION SEEMED TO BE DUE TO DETERIORATION. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892733 ↗
• MalfunctionJun 25, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE INSTRUMENT SEEMED TO BE BENT AND DOESN'T FIT INTO THE NAVLOCK TRACKER. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10196883 ↗
• MalfunctionFeb 11, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE AWL TIP WAS REPORTED TO BE "DEFECTIVE". THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9693440 ↗
• MalfunctionMay 9, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE AWL AND PASSIVE PLANAR PROBE WERE DAMAGED BY A DRILL/BURR. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8596137 ↗
• 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 8513499 ↗
• MalfunctionMar 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION POST-OPERATIVELY REGARDING A NAVIGATION DEVICE USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS A TRACKER ATTACH FAILURE DUE TO FORMATION, THE TRACKER COULD NOT BE ATTACHED SMOOTHLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8387179 ↗
• MalfunctionDec 26, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE AWL SHARP BLOCKED THE NAVLOCK AFTER SURGERY. THERE WAS NO DELAY IN SURGERY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196950 ↗
• MalfunctionDec 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAD A DAMAGED AWL TIP INSTRUMENT. THROUGH HAMMERING ON THE NAVIGATED FRAME COMPONENT INSTRUMENTS THERE HAS BEEN DAMAGE TO THE AWL TIPS IN THE RING WHERE THE RATCHETING HANDLE LOCKS ON TO THE AWL. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8181438 ↗
• MalfunctionOct 23, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT ALL THE PARTS OF THE NAV LOCK SET WERE UNABLE TO BE ATTACHED SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THE SURGERY WAS COMPLETED WITH NO DELAY AND NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996762 ↗
• MalfunctionOct 19, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR INTRA-OPERATIVELY FOR AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT EACH TIP OF THE AWL TIP AND THORACIC PROBE TIP WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND NO KNOWN IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7985438 ↗
• MalfunctionOct 15, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT POST-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE AWL SHARP BLOCKED THE NAVLOCK AFTER SURGERY. THERE WAS NO DELAY IN SURGERY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7964721 ↗
• MalfunctionOct 12, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE AWL SHARP BLOCKED IN THE NAVLOCK DURING SURGERY. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962049 ↗