N/A 3280006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00721902798214), received between Jan 15, 2025 and Jan 19, 2025 — 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 18, 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.

• MalfunctionJan 19, 2025Break; Break

  INFORMATION IS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A SPINAL OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH DEGENERATIVE DISC COLLAPSE AND STENOSIS ADJACENT TO A PREVIOUS LUMBAR FUSION. IT WAS REPORTED THAT THE INSTRUMENTS / IMPLANTS BROKE. THE MALFUNCTION WITH THE CAGE IS THAT THE PEEK PORTION THAT HAS THE THREADS FOR THE INSERTER TO GRAB ONTO BROKE OFF DURING INSERTION. THE PEEK REMAINED ON THE INSERTER AND THE CAGE WAS ABLE TO BE RETRIEVED FROM THE DISC SPACE AND NEW ONE IMPLANTED. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187775 ↗
• MalfunctionJan 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A UTERINE CURETTE USED IN ANTE RIOR LUMBAR INTERBODY FUSION (ALIF) THERAPY. IT WAS REPORTED THAT THE RING PART OF THE CURETTE WAS FRACTURED AND IT WAS NOTICED DURING CLEAN-UP. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158244 ↗