NavLock™ 9734680Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00763000054205), received between Sep 11, 2018 and Aug 25, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442972 ↗
• MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583784 ↗
• MalfunctionOct 21, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT A THORACIC PROBE THAT WAS RECENTLY PURCHASED WAS FOUND TO BE BENT DURING A PROCEDURE. LENGTH OF DELAY WAS UNKNOWN. IMPACT ON PATIENT OUTCOME UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A SACROILIAC AND THORACOLUMBAR PROCEDURE WAS PERFORMED, THE ISSUE WAS NOTICED POST-OPERATIVE, THERE WAS NO IMPACT ON PATIENT OUTCOME, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353819 ↗
• MalfunctionSep 5, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A STRAIGHT THORACIC PEDICLE PROBE ABRUPTLY SNAPPED WHILE IT WAS BEING REMOVED FROM THE LEFT SIDE OF THE S1 PEDICLE. A FRAGMENT OF THE BROKEN PROBE WAS RETAINED INSIDE THE PATIENT, AND THERE WAS CONCERN REGARDING THE INTEGRITY OF THE PROBE. THE SURGEON DECIDED TO LEAVE THE RETAINED FRAGMENT IN THE PATIENT, CONSIDERING IT THE SAFER OPTION. THIS ISSUE CAUSED LESS THAN 1 HOUR SURGICAL DELAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22978508 ↗
• MalfunctionJul 28, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACKER WAS STUCK ON THE THORACIC PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639353 ↗
• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT 35MM OF THE THORACIC PROBE TIP BROKE OFF WHEN USING THE PROBE FOR S2AI (ALAR-ILIAC) SCREWS. IT WAS NOT POSSIBLE TO REMOVE. THE BROKEN PORTION SAT IN THE BONE AND MUSCLE AROUND THE PELVIS. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY REQUIRED DUE TO THE REPORTED ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THERE WAS AN 8-10 MINUTE DELAY TO THE PROCEDURE DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564950 ↗
• MalfunctionJul 7, 2025Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  IT WAS REPORTED THAT IT GOT DEFORMED DURING PROBING. THE ISSUE WAS DISCOVERED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418997 ↗
• MalfunctionMar 16, 2025Mechanical 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. THE PATIENT HAD VERY SCLEROTIC BONE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615571 ↗
• MalfunctionFeb 11, 2025Material Fragmentation; Material Fragmentation

  2023-SEP-27 (B)(4) (REP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVLOCK THORACIC PROBE TIP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356132 ↗
• MalfunctionFeb 3, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298307 ↗
• MalfunctionJan 14, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE THORACIC PROBE BROKE OFF IN THE PATIENT'S SACRUM. THE SURGEON WAS NOT ABLE TO REMOVE IT. THERE WAS A LESS THAN ONE HOUR DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150203 ↗
• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT WHILE TRYING TO CREATE A TAP HOLE IN THE PATIENT'S PEDICLE. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TIP OF THE INSTRUMENT WAS BENT WHILE TRYING TO CREATE A TAP HOLE IN THE PATIENT'S PEDICLE UNDER NORMAL USE. THIS WAS DUE TO AN UNUSUALLY HARD CORTICAL BONE FROM PREVIOUS FUSION OVER THE 30 YEARS. THE HEALTH CARE PROFESSIONAL ADVISED THAT A LARGE AMOUNTS OF BONE GRAFT APPEARED TO HAVE BEEN USED DURING THAT PROCEDURE. THE SITE RETRIEVED ANOTHER SET AND THE CASE WAS COMPLETED WITHOUT DELAY, OR INJURY TO THE PATIENT. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904051 ↗
• MalfunctionSep 26, 2024Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE INSTRUMENT PROBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313975 ↗
• MalfunctionJun 13, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE IN SURGERY, THE TIP OF A PROBE BEING USED IN A NAVLOCK, BROKE OFF INSIDE OF THE PATIENT. THE TIP OF THE PROBE WAS LEFT IN THE PATIENT. THERE WAS NO DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19528807 ↗
• MalfunctionFeb 20, 2024Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS USING THE STRAIGHT THORACIC PROBE ON THE LEFT 5 PEDICLE, WHEN THE TIP OF THE PROBE BROKE OFF INTO THE PEDICLE. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738154 ↗
• MalfunctionOct 23, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE TAP SNAPPED OFF WHILE IN THE PEDICLE OF PATIENT, A SCREW REMOVAL AND BURRING WAS REQUIRED TO REMOVE. THE PROBE WAS MALLETED DURING SURGERY AND THE SHAFT GOT STUCK/LODGED IN NAVLOCK FRAME. THE SITE WAS UNABLE TO FREE IT. THERE WAS AN HOUR OR LONGER DELAY IN SURGERY. THE ISSUE OCCURRED POST-INCISION. THE PATIENT DID NOT SUFFER ANY ADDITIONAL DAMAGE DUE TO THE INCIDENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17985310 ↗
• InjuryMar 8, 2023Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE BROKE WHILE BEING MALLETED INTO THE PATIENT¿S PEDICLE, ABOUT 40MM DEEP. THE SURGEON WAS DRILL DRILLING AROUND THE PIECE TO GET IT OUT, BUT WOULD HAVE DRILLED OUT A LOT OF THE PEDICLE BY THE TIME HE GOT IT OUT. THE SURGEON DECIDED TO LEAVE THE TIP OF THE PROBE (APPROXIMATELY 37 MM) IN THE PATIENT'S PEDICLE, AND VERTEBRAL BODY DUE TO SUSPECTED MORE HARM THAN BENEFIT BY REMOVING IT. ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON DRILLED AROUND THE SCREW SLIGHTLY, AND TRIED TO PULL THE BROKEN PIECE OUT WITH A FEW DIFFERENT INSTRUMENTS, BUT STOPPED OUT OF CONCERN THAT TRYING TO REMOVE IT WOULD DO MORE HARM THAN GOOD. THE SURGEON NOTED THAT THEY PUT A LOT OF FORCE ON THE MALLET, AND THE SURGEON NOTED THIS, TO PARAPHRASE, "THAT THIS WOULD NOT HAVE BEEN A PROBLEM ON MOST OF HIS PATIENTS, BUT THIS PATIENT'S BONE WAS VERY DENSE". THE PATIENT WAS NOT ABLE TO RECEIVE THE FULL PLANNED FUSION ON ONE SIDE (LUMBAR 3 TO LUMBAR 5) SINCE THE PIECE WAS STUCK IN THE RIGHT LUMBAR 4 PEDICLE. THERE WAS NO PLAN FOR AN ADDITIONAL SURGERY AT THAT TIME. THIS OCCURRED INTRAOPERATIV

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Tissue Injury

  MAUDE report 16506342 ↗
• MalfunctionAug 31, 2022Break

  SURGEON WAS PUTTING A PEDICLE SCREW IN THE SPINE WHEN THE MEDTRONIC NAVIGATION PROBE TIP BROKE INSIDE THE PEDICLE. SURGEON ATTEMPTED TO REMOVE AND WAS UNABLE TO. SURGEON FELT RISKS OUTWEIGHED THE BENEFIT, AND TIP WAS LEFT IN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15327046 ↗
• MalfunctionApr 3, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON BENT A THORACIC PROBE DURING A CASE. IT WAS UNKNOWN IF THE PROBE WAS STILL ABLE TO VERIFY AFTER THE DAMAGE. A DIFFERENT PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A LESS THAN 1 HOUR DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922086 ↗
• MalfunctionApr 1, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE THORACIC PROBE'S PROXIMAL END WAS DAMAGED, DUE TO MALLETING, AND CANNOT INTERFACE WITH THE TRACKER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9911181 ↗
• MalfunctionNov 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION DEVICES USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURES. IT WAS REPORTED THAT THREE PROBES WERE ALL DAMAGED IN THE SAME SPOT. IT WAS NOTED THAT THE CLINICAL DETAILS OF THE CASES WERE UNKNOWN BY THE SITE AND THAT THE SITE USED A MALLET ON THE INSTRUMENTS. THERE WAS A LESS THAN HOUR SURGICAL DELAY AND NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371954 ↗
• MalfunctionNov 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION DEVICES USED FOR SACROILIAC AND THORACOLUMBAR PROCEDURES. IT WAS REPORTED THAT THREE PROBES WERE ALL DAMAGED IN THE SAME SPOT. IT WAS NOTED THAT THE CLINICAL DETAILS OF THE CASES WERE UNKNOWN BY THE SITE AND THAT THE SITE USED A MALLET ON THE INSTRUMENTS. THERE WAS A LESS THAN HOUR SURGICAL DELAY AND NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371937 ↗
• MalfunctionNov 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THERE WERE THREE THORACIC PROBE TIPS THAT WERE DAMAGED AND STUCK INTO TWO NAVLOCK ORANGE TRACKERS. NO WAS PATIENT PRESENT AT TIME OF DISCOVERY.

  Patient problems: No Patient Involvement

  MAUDE report 9315922 ↗
• MalfunctionOct 21, 2019Material 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 SITE HAD ISSUES WITH THEIR TRACKERS AND PROBES BEING JAMMED IN THE INSTRUMENTS. IT WAS NOTED THAT THIS WAS THE ACCOUNT'S FIRST TIME USING THE INSTRUMENTS. IT WAS ALSO NOTED THAT THE INSTRUMENTS SHOWED SIGNS OF DAMAGE AS SOME WERE STUCK TOGETHER. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THE INSTRUMENTS WHICH VERIFIED. THERE WAS NO IMPACT TO PATIENT OUTCOME. THERE WAS A 2 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9215256 ↗
• MalfunctionOct 9, 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 THE SITE HAS A DAMAGED THORACIC PROBE. IT WAS STATED THE THORACIC PROBE TWISTED/ROTATED UPON INSERTION IN THE PEDICLE. IT WAS ALSO NOTED THE INSTRUMENT WOULD NOT FIT INTO ANY OF THE TRACKERS. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9172788 ↗