EIT PLIF cage PUI31106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557820612), received between Feb 14, 2023 and Feb 14, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2023, THE SURGEON VERBALIZED THAT THE PATIENT HAD VERY HARD BONE DURING THE DISC PREPARATION PORTION OF THE CASE. THE CAGE WAS INSERTED AND ROTATED USING A LOT OF FORCE AND TORQUE. THE CAGE BROKE AT THE JUNCTION OF WHERE THE INSERTER MEETS THE CAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. FRAGMENTS WERE GENERATED BUT THE RETAINED PIECE WAS ATTACHED TO THE INSERTER AND DID NOT INVOLVE ADDITIONAL INTERVENTION TO REMOVE. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT OUTCOME WAS GOOD AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE EIT PLIF, H 11MM, 12°, 26/9. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371613 ↗