N/A 5480131VRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994429773), received between Apr 6, 2022 and May 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A DRIVER TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE REPORTED PRODUCT WAS USED MULTIPLE TIMES. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228041 ↗
• MalfunctionApr 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR DEGENERATIVE DISC DISEASE. PROCEDURE OR THERAPY PERFORMED WAS L3-5 OLIF, L3-5 POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018849 ↗