N/A 9734435 (UDI 00613994759610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994759610), received between Dec 22, 2016 and Jan 3, 2018 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2018Bent; Material Integrity Problem; Bent; Material Integrity Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING SPINAL FUSION PROCEDURE, THE SURGEON USED A MALLET TO HAMMER A AWL TACTILE INSTRUMENT INTO THE PEDICLE. IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REDIRECTED THE INSTRUMENT WHILE IT WAS IN THE BONE. WHEN THE INSTRUMENT WAS REMOVED FROM THE PEDICLE, THE TIP OF THE INSTRUMENT WAS BENT. 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; No Known Impact Or Consequence To Patient

  MAUDE report 7162552 ↗
• MalfunctionJul 13, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION AN INSTRUMENT WAS DAMAGED. PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION SYSTEM. NO INFORMATION WAS PROVIDED ON THE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710945 ↗
• MalfunctionJul 13, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE AN INSTRUMENT WAS DAMAGED. SURGERY WAS COMPLETED WITH THE USE OF NAVIGATION. NO INFORMATION WAS PROVIDED ON THE DELAY OF PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710921 ↗
• MalfunctionJun 27, 2017Bent; Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE THE TIP OF THE INSTRUMENT WAS FOUND BENT WHEN THE INSTRUMENT WAS REMOVED FROM PEDICLE DURING A POSTERIOR INSTRUMENTED FUSION. THERE WAS NO IMPACT ON PATIENT. DELAY TO SURGERY WAS LESS THAN 1 HOUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6670201 ↗
• MalfunctionJun 21, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE TACTILE AWL COULD NOT REMAIN IN THE TERA TRACKER BEING USED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR 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 6658494 ↗
• MalfunctionMay 18, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT THAT WHILE IN A SPINAL FUSION PROCEDURE, A SITE'S TACTILE PROBE WAS DAMAGED. 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 6577334 ↗
• MalfunctionJan 6, 2017Bent; Material Deformation; Bent; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE'S STRAIGHT TACTILE AWL WAS VISIBLY BENT AND HAS A DISTANCE TO DIVOT OF 1.9. THE INSTRUMENT STILL VERIFIES, HOWEVER, THE SITE IS CONCERNED IT WILL BEND FURTHER WITH ANY STRAIN. 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 6231240 ↗
• MalfunctionJan 6, 2017Bent; Material Deformation; Bent; Material Deformation

  A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT WHILE IN A SPINE PROCEDURE, WHEN PLACING AN ILIAC SCREW, THE SURGEON BENT THE TACTILE AWL. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. A SECOND AWL WAS BROUGHT IN TO CONTINUE THE PROCEDURE TO COMPLETION WITH THE USE OF NAVIGATION. 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 6230807 ↗
• MalfunctionDec 22, 2016Bent; Bent

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION THE TACTILE AWL BECAME BENT. THE SURGEON HAD THE TACTILE AWL PLACED IN THE PEDICLE, THEY TRIED TO CHANGE DIRECTIONS AND THEN AFTER REMOVING DISCOVERED THE DAMAGE, 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 6198119 ↗