N/A 9735278 (UDI 00763000214289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000214289), received between Feb 10, 2021 and Jun 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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.

• MalfunctionJun 4, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED INTRAOPERATIVELY DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. THE TIP OF THE DRIVER BROKE WHILE BEING USED INSIDE OF THE PATIENT. HOWEVER, THE TIP WAS RETRIEVED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146409 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE RATCHETING HANDLE WAS BROKEN AND NO LONGER RATCHETED WHEN PUTTING SCREWS IN. IT WAS NOTED THAT THE TIP SHEARED OFF. THERE WAS NO FRAGMENTATION IN THE PATIENT. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069161 ↗
• MalfunctionJun 6, 2023Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENT(S) HAD BEEN USED A LOT AND NO LONGER WORKED AS THEY WERE SU PPOSE TO. THERE WAS NO PATIENT IMPACTED BY THE USE OF THE INSTRUMENT(S) AND UPGRADE REPLACEMENT WAS REQUIRED TO KEEP UP WITH VOLUME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069160 ↗
• MalfunctionJul 19, 2021Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE MOST LIKELY CAUSE OF THE ISSUE WAS SUSPECTED TO BE DUE TO THE PATIENT HAVING A HARD BONE AND THAT AN EXCESSIVE AMOUNT WAS BEING PLACED ON THE DRIVER, CAUSING THE TIP OF IT TO SHEAR OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189437 ↗
• MalfunctionMar 14, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS 30-60 SECOND DELAY DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478987 ↗
• MalfunctionFeb 10, 2021Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT CAUSE MAY HAVE BEEN THAT THE PATIENT'S BONE WAS A LITTLE MORE SCLEROTIC THAN USUAL, WHICH COULD HAVE LED TO A HIGHER INSERTION TORQUE ON THE DRIVER. THE DRIVER HAS ALSO BEEN OVER A HUNDRED TIMES, SO THIS MAY HAVE MADE IT WEAKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308222 ↗