ACDF Stand Alone Cervical 03.18.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040725644), received between Apr 25, 2025 and Apr 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• InjuryApr 25, 2025Difficult or Delayed Positioning; Loose or Intermittent Connection; Difficult or Delayed Positioning; Loose or Intermittent Connection

  DURING INSERTION OF THE LOCKING SCREW THE FLUSH LOCK PLATE CAME LOOSE FROM THE CAGE. THE SURGEON RECOUPLED THE PLATE AND THE CAGE AND TRIED AGAIN TO INSERT THE SCREW BUT THE PLATE CAME LOOSE AGAIN. NEW CAGE AND PLATE WERE USED TO COMPLETE THE SURGERY. THE SAME ISSUE OCCURRED AGAIN WITH A SECOND CAGE ON A DIFFERENT LEVEL: THE PLATE CAME LOOSE, THE SURGEON RECOUPLED IT TO THE CAGE AND IN THIS CASE WAS ABLE TO COMPLETE SCREW INSERION WITHOUT ISSUES. PATIENT WAS YOUNG WITH GOOD BONE QUALITY, DISTRACTION WAS PERFORMED WITH CASPAR DISTRACTOR. IT WAS REPORTED THAT THE SURGEON DID NOT TRY TO REPOSITION THE CAGES ONCE IN SITU AND BEFORE SCREWING. 20 TO 30 MINUTES OF DELAY REPORTED, TOTAL SURGERY TIME AROUND 2H.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907807 ↗