NA II-1-0431Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613020250), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 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.

• InjuryMar 8, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ONE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. DURING THE PROCEDURE, AFTER THE IMPLANTED DEVICES HAD BEEN PLACED AND EXPANDED, THE SURGEON PROCEEDED TO FILL THE SPACE WITH AUTOLOGOUS BONE GRAFT. WHILE IMPLANTING THE GRAFT, THE SURGEON ATTEMPTED TO USE A MALLET TO DRIVE THE GRAFT DOWN THE FUNNEL. IN DOING SO, THE FORCE TO THE FUNNEL IMPACTED THE INTERBODY CONSTRUCT AND RESULTED IN MIGRATION OF THE CONSTRUCT INTO THE RETROPERITONEAL SPACE, WHERE IT COULD NOT BE RETRIEVED. A NEW INTERBODY CONSTRUCT WAS SUCCESSFULLY PLACED, FILLED, AND THE POSTERIOR INCISION WAS CLOSED. SUBSEQUENTLY, GENERAL SURGERY ASSISTED IN REMOVAL OF THE CONSTRUCT ANTERIORLY. THE ADDITIONAL SURGICAL APPROACH RESULTED IN A PROCEDURAL DELAY OF APPROXIMATELY ONE HOUR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435421 ↗