N/A 961-576Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00721902467738), received between Mar 13, 2017 and Jan 23, 2026 — classified as 15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREW OF THE CLAMP DID NOT TIGHTEN, AND THERE WAS A STOPPER DISCONNECTION WITH THE DRILL GUIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164800 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRE-OPERATIVELY OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FIXATION SCREW CAME OFF DURING PRE-USAGE PREPARATION, SO IT COULD NOT BE FIXATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659257 ↗
• MalfunctionAug 5, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SMALL CLAMP WAS DEFECTIVE. THE SCREW COULD NO LONGER BE TURNED. IT WAS REPORTED THAT THE SUSPECTED CAUSE OF THE REPORTED ISSUE WAS NORMAL WEAR & TEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716931 ↗
• MalfunctionAug 15, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A LUMBAR FUSION PROCEDURE. THE ISSUE OCCURRED PREOPERATIVELY AND THE PATIENT WAS IN THE ROOM BUT, ANESTHESIA HAD NOT BEEN ADMINISTERED AND NO INCISION HAD BEEN MADE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED SMALL BLACK SURETRAK CLAMP WHERE THE SCREWS WERE STRIPPED. THE SITE OPENED ANOTHER SET AND USED A CLAMP FROM THAT SET TO CONTINUE THE CASE. THE SURGERY WAS COMPLETED WITH NAVIGATION AND NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898078 ↗
• MalfunctionMar 31, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A BROKEN INSTRUMENT THAT NEEDED REPLACEMENT. THE SCREW THREAD WAS DEFRAGMENTED AND LOOSE ON THE SURETRAK SMALL CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8468031 ↗
• 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 8034450 ↗
• MalfunctionMar 20, 2018Material Deformation; Material Deformation

  A MANUFACTURER REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE CLAMP WAS FOUND TO BE DAMAGED. IT WAS REPORTED THAT A SECOND CLAMP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7354595 ↗
• MalfunctionMar 9, 2018Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT DURING ORTHO (THA AND TKA) BASED PROCEDURE, THE SURETRAK SMALL CLAMP HAD A STRIPPED SCREW. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329326 ↗
• MalfunctionJan 16, 2018Naturally Worn; Naturally Worn

  AFTER A PROCEDURE IT WAS NOTICED THAT THE SMALL SURETRAK CLAMP SCREW WAS WORN AND DAMAGED. NO IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7197415 ↗
• MalfunctionAug 23, 2017Material Deformation; Material Deformation

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

  Patient problems: No Patient Involvement

  MAUDE report 6814568 ↗
• MalfunctionJul 6, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SURETRAK CLAMP BEING USED WAS DEFORMED. THE DEFORMATION WAS REPORTED TO BE WIDENED. THE SITE ELECTED TO USE A SEPARATE CLAMP TO COMPLETE 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 6691565 ↗
• MalfunctionJun 22, 2017Material Deformation; Material Deformation

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

  Patient problems: No Patient Involvement

  MAUDE report 6661270 ↗
• MalfunctionJun 6, 2017Mechanical Problem; Mechanical Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6616377 ↗
• 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, A SPINAL CLAMP WAS REPORTED TO HAVE A DAMAGED SCREW THREAD. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6446540 ↗
• MalfunctionMar 13, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SCREW FOR THE SMALL SURETRAK CLAMP WAS STRIPPED. NO PATIENT WAS PRESENT WHEN THIS ISSUE WAS DISCOVERED.

  Patient problems: No Patient Involvement

  MAUDE report 6398496 ↗