Aero-C 48894050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327124811), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionMar 29, 2017Disassembly; Difficult to Insert; Disassembly

  IT WAS REPORTED THAT; THE ANCHOR OF THE CAGE WOULD NOT FULLY INSERT INTO BONE. THE PILOT CUTTER WOULD NOT SEAT ALL THE WAY INTO BONE EITHER. THE SURGEON ATTEMPTED TO DRIVE THE CUTTER SEVERAL TIMES AND WE TRIED MULTIPLE DIFFERENT PILOT CUTTERS. THEN HE ATTEMPTED TO DRIVE THE ANCHOR INTO VERTEBRAL BODY AND IT STOPPED AFTER DRIVING THROUGH BONE APPROXIMATELY 85% OF THE WAY. WE ATTEMPTED SEVERAL DIFFERENT TAMPS AS WELL AS THE FREE HAND TAMP. AFTER TRYING FOR 5-10 MINUTES THE SURGEON WAS NOT WILLING TO APPLY ANY MORE FORCE VIA MALLETING THE ANCHOR. THE SURGEON WAS MALLETING AT A FORCE GREATER THAN NORMAL FOR CERVICAL IMPLANT PLACEMENT. THE BLADE WAS LEFT WITHOUT BEING FULLY INSERTED. THE ASSOCIATED SURGICAL DELAY WAS 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443458 ↗