N/A 9734904Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000208776), received between Mar 6, 2020 and Apr 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE BACK PORTION OF THE INSERTER'S LOCKING INNER PIECE BROKE OFF WHEN MALLEATING IN THE INTERBODY CAGE. PATIENT PRESENT. UNKNOWN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911329 ↗
• MalfunctionNov 20, 2023Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE INSTRUMENT BROKE OFF INSIDE OF THE PATIENT ANATOMY. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172448 ↗
• MalfunctionFeb 24, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT PRE-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH DEGENERATIVE SCOLIOSIS. AFTER INSERTING THE CAGE TO THE L2/3 LEVEL, THE INSERTER WAS REATTACHED FOR ADDITIONAL INSERTION AND THE INSERTION WAS ATTEMPTED. BUT IT DID NOT MOVE AND THE CAGE BROKE FROM THE ATTACHMENT PART WHEN HIT WITH A HAMMER. THE BROKEN PARTS WERE COLLECTED AND DISCARDED DUE TO BLOOD CONTAMINATION. THE CAGE REMAINED IN THE PATIENT AND WAS LEFT AS IT WAS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PLAN FROM THE SITE THAT A REVISION PROCEDURE WOULD BE PERFORMED. THE FRAGMENT PIECES REMAINED AT THE IMPLANT LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592284 ↗
• MalfunctionFeb 9, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT PRE-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH DEGENERATIVE SCOLIOSIS. AFTER INSERTING THE CAGE TO THE L2/3 LEVEL, THE INSERTER WAS REATTACHED FOR ADDITIONAL INSERTION AND THE INSERTION WAS ATTEMPTED. BUT IT DID NOT MOVE AND THE CAGE BROKE FROM THE ATTACHMENT PART WHEN HIT WITH A HAMMER. THE BROKEN PARTS WERE COLLECTED AND DISCARDED DUE TO BLOOD CONTAMINATION. THE CAGE REMAINED IN THE PATIENT AND WAS LEFT AS IT WAS. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PLAN FROM THE SITE THAT A REVISION PROCEDURE WOULD BE PERFORMED. THE FRAGMENT PIECES REMAINED AT THE IMPLANT LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497214 ↗
• MalfunctionMar 6, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) INSERTER WAS DEFECTIVE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9800564 ↗