N/A 5485147VRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994429667), received between Jul 31, 2023 and May 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH DDD. IT WAS REPORTED THAT THE DRIVER BROKE. THE TIP OF THE DRIVER BROKE DURING ADDITIONAL TIGHTENING OF SET SCREWS. I BELIEVE THE DRIVER MAY HAVE NOT BEEN FULLY SEATED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094171 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENT WAS BROKEN. NO PATIENT WAS INVOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302285 ↗
• MalfunctionJan 20, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE REGARDING INSTRUMENTS INSPECTED DURING A QUARTERLY AUDIT OF SETS. IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193057 ↗
• MalfunctionOct 10, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN INTRA-OPERATIVELY TRYING TO ADVANCE AND BACK OUT SCREWS. MULTIPLE DRIVERS WERE BROKEN. PATIENT HAD TOUGH BONE. THE PATIENT WAS NOT AFFECTED BY BROKEN DRIVERS AND THE BROKEN PIECES WERE RECOVERED. NO PATIENT INJURY / COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902554 ↗
• MalfunctionJul 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L1 BURST FX. IT WAS REPORTED THAT THE INSTRUMENT WAS SHEARED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17422976 ↗