NavLock 9734734 (UDI 00643169101968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169101968), received between Oct 26, 2016 and Mar 11, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP WAS BENT. THERE WAS POOR RECOGNITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575508 ↗
• MalfunctionMar 3, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507294 ↗
• MalfunctionJul 12, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BOTH THE GREEN AND ORANGE TRACKER DID NOT HOLD THE INSTRUMENTS ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151093 ↗
• MalfunctionJan 29, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS INTERNAL DAMAGE TO THE ORANGE, GREEN, AND VIOLET TRACKERS. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9643578 ↗
• MalfunctionDec 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE NAVIGATED OSTEOTOME WITH THE GREEN NAVLOCK ATTACHED WAS STUCK ON THE RATCHET HANDLE. THE SITE COULD NOT GET THE HANDLE TO RELEASE THE INSTRUMENT. THE INSTRUMENTS WERE STILL FUNCTIONAL, THEY JUST COULD NOT GET THE HANDLE TO RELEASE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9526209 ↗
• MalfunctionSep 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE HAD 3 DEFECTIVE TRACKERS (GREEN, GREY, ORANGE). NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9134705 ↗
• MalfunctionSep 4, 2019Imprecision; Imprecision

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THERE WAS NO IMPACT TO THE PATIENT OUTCOME. THE TRACKERS WERE NOT BE RETURNED AS THE ACCOUNT WANTED TO KEEP THEM. THE MANUFACTURER REPRESENTATIVE TESTED THE TRACKERS AT THE ACCOUNT AND RETURNED THEM TO THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962002 ↗
• MalfunctionApr 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION INSTRUMENT OUTSIDE OF A PROCEDURE. THE REP INDICATED THAT WHEN THE INSTRUMENT CAME BACK FROM STERILIZATION THERE WAS A BROKEN HOLDING/CLAMPING MECHANISM FOR THE NAVLOCK. THERE WAS NO PATIENT INVOLVED WITH THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8546568 ↗
• MalfunctionApr 18, 2019Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING SURGERY, THE GREEN NAVLOCK TRACKER WAS NOT ALWAYS RECOGNIZED BY THE CAMERA, MOSTLY WHEN THE NAVLOCK WAS NOT LOOKING STRAIGHT TO THE CAMERA. THE GREEN NAVLOCK WAS BEING USED WITH A SCREW DRIVER. THE SURGEON NOTED THAT IT HAPPENED OFTEN WITH THIS GREEN NAVLOCK. THERE WERE NO PROBLEMS WITH THE ORANGE, GREY, AND PURPLE NAVLOCK TRACKERS. THERE WAS NO DELAY DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT THE SPHERES WERE CONTROLLED AND HAD BEEN CLEANED. TROUBLESHOOTING FOUND THAT THE NAVLOCK GEOMETRY ERROR WAS AROUND 0.48 WHEN NAVIGATING AND UP TO 0.6 WHEN NOT NAVIGATING. IT WAS NOTED THAT ONE PIN SEEMED TO BE SLIGHTLY LOOSE AND COULD NOT BE TURNED BY HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8528420 ↗
• MalfunctionApr 10, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THE SITE WAS ABLE TO VERIFY AN INSTRUMENT WITH THE UNIVERSAL GREEN TRACKER AT THE BEGINNING OF THE PROCEDURE, HOWEVER, WHEN THE SITE ATTEMPTED TO RE-VERIFY DURING THE PROCEDURE, VERIFICATION WAS NOT SUCCESSFUL. IT WAS NOTED DIFFERENT INSTRUMENT TIP WAS USED WITHOUT RESOLVE. IT WAS ALSO NOTED THE SPHERES WERE REPLACED WITHOUT RESOLVE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED A LESS THAN ONE-HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501937 ↗
• MalfunctionJan 15, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE DEFECTIVE TRACKER WAS NOT ABLE TO VERIFY.

  Patient problems: No Patient Involvement

  MAUDE report 8247766 ↗
• MalfunctionNov 26, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT TRACKERS WERE BAD UPON RECEIVING. THE VIOLET TRACK IS MISSING A SPHERE POST AND THE GREEN TRACKER HAS LOOSE LOCKING MECHANISM SO INSTRUMENTS ARE NOT STAYING PROPERLY ATTACHED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8103067 ↗
• MalfunctionMay 7, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF PROCEDURE, THE GREEN NAVLOCK TRACKER WAS NOT TRACKING ACCURATELY. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7490254 ↗
• MalfunctionOct 20, 2017Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, AN IMPRECISION WAS OBSERVED WHEN USING THE NAVLOCK TRACKER. THE IMPRECISION WAS NOTED TO HAVE BEEN ONE CENTIMETER AND THE ISSUE WAS RESOLVED BY SWITCHING TRACKERS FOR THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6965429 ↗
• MalfunctionJun 1, 2017Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE DRILL USED ALONGSIDE THE NAVLOCK TRACKER COULD NOT BE MOVED. THE SURGEON ELECTED TO CONTINUE THE PROCEDURE WITH NON-NAVIGATED DRILL BITS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6606251 ↗
• MalfunctionMar 24, 2017Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CASE THE SITE TAPPED A HOLE USING A MEDTRONIC TAP AND WHEN THE TRACKED DRIVER WAS BROUGHT TO THE HOLE, THE SYSTEM SHOWED THAT THE DRIVER WAS NOT FOLLOWING THE SAME TRAJECTORY AS THE TAP. THE MEDTRONIC REPRESENTATIVE FOUND THAT WHEN THE TRACKER WAS MOVED ON THE DRIVER (TILTED IT AT DIFFERENT ANGLES TO THE CAMERA) THE MODEL OF THE DRIVER SHOWN ON THE SYSTEM WOULD SHIFT UP AND DOWN ALONG THE TRAJECTORY BY A FEW MM AS THE TRACKER WAS ROTATED. IT WAS ALSO FOUND THAT WHEN THE CAMERA WAS MOVED THE TRACKER WOULD REMAIN IN A FIXED POSITION, THE MODEL OF THE DRIVER WOULD MOVE UP AND DOWN THE TRAJECTORY BY A FEW MM AS THE CAMERA WAS MOVED AROUND. ADDITIONALLY, TRACKING DIFFICULTY WAS OBSERVED WITH SOME OF OTHER INSTRUMENTS. THERE WAS NO PATIENT IMPACT OR DELAY IN SURGERY REPORTED. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6431887 ↗
• MalfunctionJan 27, 2017Mechanical Problem; Mechanical Problem

  A SITE SURGEON REPORTED THAT HE HAD HURT ONE OF HIS FINGERS DUE TO AN UNEXPECTED NAVLOCK SPIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6282678 ↗
• MalfunctionJan 27, 2017Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT THERE WAS AN UNEXPECTED NAVLOCK SPIN. THERE WAS NO PATIENT IMPACT REPORTED AND NO REPORTED DELAY IN SURGERY. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6282677 ↗
• MalfunctionDec 13, 2016Mechanical Problem; Device Inoperable; Material Deformation; Mechanical Problem; Device Inoperable; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S GREEN NAVLOCK TRACKER AND THEIR 3.75 SOLERA TAP BECAME FUSED TOGETHER WHEN THE SURGEON WAS USING THESE DEVICES WITH A POWEREASE DRILL. THE SURGEON STATED THAT HIS GLOVE MAY HAVE GOTTEN CAUGHT BETWEEN THE TAP AND THE TRACKER, AS WELL. THE SURGEON USED A DIFFERENT TRACKER AND A DIFFERENT TAP COMBINATION TO CONTINUE THE PROCEDURE. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6170102 ↗
• MalfunctionNov 15, 2016Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, AN AWL-TIP-TAP INSTRUMENT AND AN INSTRUMENT TRACKER BECAME BOUND TOGETHER, AND COULD NOT BE SEPARATED, OR USED FOR NAVIGATION. IT WAS REPORTED THAT THE BOUND PARTS WERE USED WITH A POWEREASE DRIVER. ALTERNATE INSTRUMENTS WERE BROUGHT IN TO BE USED TO CONTINUE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY OF THERAPY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104678 ↗
• MalfunctionOct 26, 2016Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, AN AWL-TIPPED TAP INSTRUMENT AND AN INSTRUMENT TRACKER BECAME BOUND TOGETHER, AND COULD NOT BE SEPARATED, OR USED FOR NAVIGATION. IT WAS REPORTED THAT THE BOUND PARTS WERE USED WITH A POWER DRIVER. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE USE OF THESE INSTRUMENTS, AND NO IMPACT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6058925 ↗