NA 9734723Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169936331), received between Mar 3, 2017 and Nov 2, 2018 — classified as 6 malfunctions.

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

• MalfunctionNov 2, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SPINE CLAMP WAS STUCK ON THE SPINAL PROCESS AND HAD TO BE PRIED OFF TO REMOVE. THE WASHER SEPARATED, WHICH CAUSED THE CLAMP TO NOT OPEN. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND A REPORTED DELAY OF LESS THAN 1 HOUR.

  Patient problems: No Patient Involvement

  MAUDE report 8035042 ↗
• MalfunctionFeb 2, 2018Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A CERVICAL SPINAL FUSION, THE SPINE CLAMP WAS FOUND TO HAVE BEEN DAMAGED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7237650 ↗
• MalfunctionOct 3, 2017Mechanical Problem; Mechanical Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6912638 ↗
• MalfunctionJun 9, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE SPINE CLAMP WASHER FELL OFF OF THE CLAMP. THE WASHER WAS RETRIEVED AND THE SITE ELECTED TO CONTINUE THE PROCEDURE WITH A DIFFERENT CLAMP. 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 6630377 ↗
• MalfunctionApr 24, 2017Material Deformation; Material Deformation

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION, THE WASHER FOR THE SPINE CLAMP BROKE OFF THE CLAMP. THE REPORTED ISSUE OCCURRED PRE-OPERATIVE AND WAS DISCOVERED WHEN THE INSTRUMENT TRAY WAS OPENED. 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 6517663 ↗
• MalfunctionMar 3, 2017Break; Material Deformation; Break; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A WASHER BROKE OFF OF THE DOUBLE PROCESS TALL CLAMP WHILE THE SURGEON WAS REMOVING IT FROM THE PATIENT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW 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 6376638 ↗