N/A 9734590 (UDI 00643169085534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169085534), received between Feb 15, 2017 and Dec 28, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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.

• MalfunctionDec 28, 2020Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITES NAVLOCK TRACKER GREY WAS DEFECTIVE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078157 ↗
• MalfunctionSep 1, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE DRIVER HAD A 2MM+ INACCURACY AT THE TIP OF THE SCREW. THE DRIVER WAS BEING USED WITH A SPINOUS PROCESS CLAMP. THE FRAME WAS ON L3 WITH THE SCREWS BEING INSERTED ON T10-L2. THE FRAME WAS FACING THE FEET OF THE PATIENT. IT WAS NOTED THAT NAVIGATION WAS ACCURATE UNTIL THE POINT OF SCREW INSERTION. OTHER INSTRUMENTS HAD NO ISSUES. WHEN PUTTING THE SCREW IN AS THE DRIVER ADVANCED, THE SCREW CONTINUALLY CHANGED POSITIONS. IT WAS NOTED THAT THE DRIVER MAY HAVE BEEN BENT, HOWEVER REGISTRATION WAS COMPLETED WITHOUT ISSUE. AUTO-REGISTRATION WAS USED. THE PROCEDURE WAS COMPLETED AS NORMAL BUT THE SURGEON NOTED THE INACCURACY. IT WAS ALSO NOTED THAT THE TRACKER THAT WAS USED WITH IT HAD A DISTANCE TO DIVOT VALUE OF 0.1-0.2MM. THE INACCURACY WAS IN THE X/Y PLANES. THERE WAS NO DELAY TO THE PROCEDURE AND NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE SCREWS WERE NOT PLACED INACCURATELY AND THAT THE PREPARATION WAS DONE CORRECTLY AND THE CORRECT SCREW PATH WAS FOLLOWED. SCREWS DID NOT HAVE TO BE REPOSITION

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10477710 ↗
• MalfunctionJul 13, 2020Imprecision; Imprecision

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE WAS NOT NOTED AND THAT THE INSTRUMENT WAS SHOWING ABOVE THE ANATOMY WHEN THE SURGEON WAS ON THE ANATOMY AT THE END OF THE CASE, BUT WAS ACCURATE AT THE BEGINNING OF CASE. IT WAS REPORTED THAT THEY WERE 50MM INACCURATE THE TAP WAS NAVIGATED BUT ONCE THE INACCURACY WAS FELT, THE SITE PROCEEDED WITHOUT NAVIGATING THE DRIVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264919 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE WAS ABLE TO GET THE THIRD PART INSTRUMENT OUT OF THE TRACKER AND THE TRACKER WAS PUT BACK INTO THE SET. THERE HAVE BEEN MULTIPLE CASES SINCE THEN WITHOUT ANY TRACKER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9182120 ↗
• 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 9134717 ↗
• MalfunctionAug 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE GREY NAVLOCK AND 5.5 TAP GOT STUCK WHEN PUT TOGETHER. THE NAVLOCK CAUSES ISSUES WITH ALL OTHER INSTRUMENTS, THE TAP CAUSES ISSUES WITH SEVERAL OTHER NAVLOCKS. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8934948 ↗
• MalfunctionApr 8, 2018Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE GREY NAV LOCK TRACKER WAS NOT RECOGNIZED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7405958 ↗
• MalfunctionJan 31, 2018Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE THE GREY NAVLOCK TRACKER ON THE IMAGING SYSTEM WAS DAMAGED. THE REPRESENTATIVE REPORTED THAT THE 'FLANGED BROKE OFF' OF THE GREY NAVLOCK TRACKER. THE BROKEN PIECE WAS RECOVERED. THERE WAS NO DELAY TO THE PROCEDURE WAS A RESULT OF THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7231064 ↗
• MalfunctionJan 30, 2018Mechanical Problem; Mechanical Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION CERVICAL CASE, WHILE USING THE POWEREASE MOTOR, THE PART BECAME JAMMED. THERE WAS NO PATIENT IMPACT REPORTED AND THE DELAY IN SURGERY WAS LESS THAN AN HOUR. SURGERY PROCEEDED AS PLANNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228509 ↗
• MalfunctionJan 4, 2018Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE DRILL LOCKED UP INSIDE OF THE TRACKER. VISUAL INSPECTION FOUND THAT THE TRACKER HAD A SCUFF ON THE INSIDE. IT WAS REPORTED THAT MULTIPLE INSTRUMENTS COULD NOT BE USED WITH THE TRACKER. IT WAS REPORTED THAT THE ISSUE WAS DISCOVERED FOLLOWING ITS USE AND THAT A SECOND TRACKER WAS USED 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 7165488 ↗
• MalfunctionMar 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN AN OPEN SPINAL FUSION PROCEDURE, THE TRACKER DISC PREP INSERTS WOULD NOT SLIDE INTO THE NAVIGATION TRACKERS. ALL COLORS AND ALL INSERTS WERE ATTEMPTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. NAVIGATION OF DISC PREP WAS ABORTED AND THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6396762 ↗
• MalfunctionMar 10, 2017Mechanical Problem; Device Operates Differently Than Expected; Material Deformation; Mechanical Problem; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT WHILE IN A SPINE PROCEDURE, THEY BROKE A GREY NAVLOCK TRACKER, AS WELL AS TWO ADDITIONAL INSTRUMENTS. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395366 ↗
• MalfunctionFeb 15, 2017Device Stops Intermittently; Device Stops Intermittently

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE INSTRUMENT WAS INTERMITTENTLY TRACKING. THEY CHANGED THE SPHERES BUT THAT DID NOT RESOLVE THE ISSUE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6332698 ↗