N/A 961-578Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00721902467714), received between Sep 26, 2016 and Nov 26, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SCREW OF THE CLAMP COULD NOT BE TIGHTENED. THERE WAS NO REPORTED DELAY, AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658969 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PRODUCT COULD BE OPENED AND CLOSED BECAUSE THE SCREW PART OF THE TRACKER MEDIUM CLAMP AND THE LARGE CLAMP WAS ADHERED. THE CAUSE WAS UNKNOWN. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396141 ↗
• MalfunctionJun 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE SURETRAK CLAMP HAD BEEN STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8737167 ↗
• MalfunctionFeb 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE CLAMP WAS DEFECTIVE. IT WAS NOT POSSIBLE TO CLOSE THE SCREW CLAMP. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8370633 ↗
• MalfunctionNov 13, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CLAMP HAD A CONNECTION FAILURE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED. ON (B)(6) 2018, GALIP2 RECEIVED FOLLOWING RESPONSE FROM (B)(6). IF THE INSTRUMENTS PASS VERIFICATION OR COULD THEY HAVE PASSED VERIFICATION? COULD NOT BE OBTAINED. THE PROVIDED INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN/ACCOUNT: YES OR NO YES.

  Patient problems: No Patient Involvement

  MAUDE report 8064664 ↗
• MalfunctionNov 2, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SCREWS WERE WORN OUT ON A FEW DEFECTIVE INSTRUMENTS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8034543 ↗
• MalfunctionNov 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DISCOVERED DAMAGED INSTRUMENTS DURING STERILE PROCESSING. THE WAS NOTED THAT THE PROBES ARE BENT, THE CLAMP SCREW IS STRIPPED AND THE REFERENCE FRAME IS BENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8029184 ↗
• MalfunctionJan 31, 2018Naturally Worn; Naturally Worn

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A PROCEDURE THE SCREW THREADS ON THE CLAMP WAS WORN. THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7231016 ↗
• MalfunctionNov 8, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE SCREW OF THE SURE TRAK MOUNT WAS WORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7011823 ↗
• MalfunctionOct 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, A SURETRAK WAS DAMAGED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6960199 ↗
• MalfunctionSep 7, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, A SURETRAK WAS DAMAGED. THE SCREW FOR THE SURETRAK WAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6849003 ↗
• MalfunctionJun 19, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE CLAMP SCREW THREAD WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6650986 ↗
• MalfunctionJun 9, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE CLAMP BEING USED WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6629668 ↗
• MalfunctionApr 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE CLAMP WAS NOT BEING RECOGNIZED DURING VERIFICATION. CASE WAS CONTINUED WITHOUT THE USE OF NAVIGATION. 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 Known Impact Or Consequence To Patient

  MAUDE report 6494840 ↗
• MalfunctionMar 17, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT SCREW THREAD IS BROKEN ON THE MEDIUM CLAMP. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6412902 ↗
• MalfunctionDec 21, 2016Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SCREW WAS BROKEN ON A CLAMP. 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 6195373 ↗
• MalfunctionDec 13, 2016Material Deformation; Material Deformation

  A SITE PURCHASING REPRESENTATIVE REPORTED THAT THEIR SURETRAK2 MEDIUM CLAMP HAD A DAMAGED SCREW. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6172061 ↗
• MalfunctionOct 15, 2016Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SITE'S CLAMP WAS HARD TO TAKE OFF, AND ONCE IT CAME OFF, IT WAS NO LONGER ABLE TO TURN IN THE RELEASE DIRECTION. NO FURTHER DETAILS REGARDING THE DAMAGE, HOW IT OCCURRED 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 6031843 ↗
• MalfunctionOct 14, 2016Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION CASE, THE SITE DISCOVERED THAT THE SCREW THREAD OF THE SURETRAK CLAMP IS STRIPPED. THERE WAS NO DELAY AS A RESULT OF THIS ISSUE, AND PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EFFECT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6030002 ↗
• MalfunctionSep 30, 2016Unstable; Material Deformation; Unstable; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE'S SURETRAK2 MEDIUM CLAMP SCREW WAS FOUND TO BE DAMAGED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 5990639 ↗
• MalfunctionSep 27, 2016Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A POSTERIOR SPINAL FUSION PROCEDURE, THE SCREW THREAD ON THE MOUNT OF THE SITE'S SURETRAK CLAMP WAS BROKEN.. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND 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 5982076 ↗
• MalfunctionSep 26, 2016Material Deformation; Unintended Movement; Material Deformation; Unintended Movement

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PLANNED MAINTENANCE (PM), FOUND THAT THE SITE'S MEDIUM SURETRAK CLAMP SLIDES, EVEN WITH THE SCREW ALL THE WAY TIGHTENED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 5978436 ↗