N/A 961-580Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00721902467691), received between Mar 30, 2017 and Feb 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 21394284 ↗
• MalfunctionMar 14, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE LARGE CLAMP WAS DAMAGED; THE LARGE CLAMP HAD A STRIPPED SCREW. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8420538 ↗
• MalfunctionDec 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACKER¿S FIXATION FAILED DESPITE TURNING THE SCREW OF THE CLAMP ON THE TRACKER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 8122756 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

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

  Patient problems: No Patient Involvement

  MAUDE report 7353363 ↗
• 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 7230880 ↗
• MalfunctionDec 27, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE SCREW INSIDE THE LARGE SURETRACK WAS STRIPPED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7149976 ↗
• MalfunctionOct 12, 2017Material Deformation; Material Deformation

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

  Patient problems: No Patient Involvement

  MAUDE report 6946618 ↗
• MalfunctionSep 28, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE THE SCREW HEAD OF THE LARGE CLAMP WAS OUTWORN. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6902517 ↗
• MalfunctionJul 18, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW ON THE SURETRAK CLAMP WAS WORN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6721230 ↗
• MalfunctionJun 15, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREW HEAD OF THE CLAMP WAS STRIPPED. THE REPORTED ISSUE RESULTED IN THE CLAMP BEING UNUSABLE AS THE DRIVER COULD NOT FIT ONTO THE TOP. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6643374 ↗
• MalfunctionMar 30, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE THREADS ON A SPINE CLAMP WERE DAMAGED AND THE CLAMP COULD NOT FUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446460 ↗