n/a 6971105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074309620), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PSEUDOARTHROSIS OF LUMBAR SPINE LUMBOSACRAL RADICULOPATHY. IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING A CAGE AT L4-5 USING THE INSERTER. THE CAGE WAS LOADED IN THE ANGLED POSITION, AND AFTER IMPLANTATION, THE INSERTER HANDLE DID NOT UNSCREW EASILY AND PRODUCED A SQUEAKING NOISE FOLLOWED BY A SNAP. UPON REMOVAL, THE THREADED SIDE OF THE CAGE INSERTER WAS FOUND TO HAVE BROKEN OFF AND REMAINED LODGED IN THE THREADS OF THE IMPLANTED CAGE. THERE WAS A PIECE OF THE THREADED INSERTER STILL THREADED IN TO THE CAGE. THE PIECE OF THE INSERTER IS STILL THREADED TO THE CAGE AND THERE IS NO PLAN TO REMOVE. ADDITIONALLY, THE DRIVER HAD BEEN USED MANY TIMES, WAS NOT GRIPPING THE SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23425410 ↗