Aero-C 48894076Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327124866), received between May 25, 2016 and Feb 24, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2017Mechanical Problem; Migration or Expulsion of Device; Device Operates Differently Than Expected; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; CAGE WAS IMPLANTED AT C3-4 TO FLUSH WITH VB. PILOT CUTTER WAS USED AS OUTLINED IN TECHNIQUE. ANCHOR WAS PLACED IN CHANNEL. UPON IMPACTION, CAGE MIGRATED ANTERIORLY ABOUT 3MM WITH THE BLADE LOCKING INTO THE CAGE. CONFIRMED ON LATERAL FLUOROSCOPY. ENTIRE CONSTRUCT WAS MALLETED INTO PLACE. SECOND ANCHOR WAS INSERTED WITHOUT ANY TROUBLE. CAGE REMAINS 1MM PROUD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6358172 ↗
• InjuryMay 25, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING FUSION C5-C6 ON AN OSTEOPOROTIC PATIENT (POOR/ MUSHY BONE QUALITY) THE VERTEBRAL BODY CRACKED/FRACTURED WHILE INSERTING THE BLADE. THE SURGERY WAS COMPLETED BY INSERTING A BLADE OVER THE FRACTURED PORTION AND INSERTING 2 SCREWS. A PLATE WAS PLACED ON C4-C5. NO ADVERSE CONSEQUENCES OF THE PATIENT REPORTED. THE PATIENT WILL BE UNDER OBSERVATION.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 5678248 ↗