Aero-C 48894066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327124750), received between Feb 5, 2018 and Jun 11, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2021Migration; Migration

  IT WAS REPORTED THAT THE BLADE OF AN AERO C CAGE BROKE OFF AND TRANSLATED POSTERIORLY AT C3 POST-OPERATIVELY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AT THIS TIME. REVISION SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987259 ↗
• InjuryMar 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SUPERIOR ANCHOR OF AN AERO C CAGE AT C5 BROKE AND MIGRATED THREE YEARS POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY IN WHICH THE MIGRATED ANCHOR WAS REMOVED BUT THE CAGE AND THE INFERIOR ANCHOR WERE LEFT IN PLACE BECAUSE THE PATIENT HAD ACHIEVED FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399190 ↗
• MalfunctionFeb 5, 2018Break; Fracture; Improper or Incorrect Procedure or Method; Fracture

  DURING THE IMPLANTING OF A CAGE, THE SURGEON MENTIONED THAT HE ANGLED THE INSERTER SLIGHTLY BOTH CEPHALAD AND CAUDAL IN ORDER TO TRY CLOSE A FISH MOUTHING DISC SPACE. THIS STRATEGY WAS IMPLEMENTED IN THE HOPES OF CATCHING MORE BONE AND EFFECTIVELY SEATING THE ANCHORS IN TO AS MUCH BONE AS POSSIBLE. THE REPRESENTATIVE WAS MADE AWARE OF THIS STRATEGY POST OPERATIVELY. THE SURGEON DOES UNDERSTAND THE CORRECT ON LABEL USE OF THE PRODUCT BUT FELT THIS ADDITIONAL TECHNIQUE WAS NECESSARY WITH THIS PARTICULAR PATIENT. WHEN THE ANCHORS WERE INSERTED, THEY ENTERED THE BONE BUT PULLED THEMSELVES OUT OF THE CAGE BECAUSE OF THE INCREASED ANGLE AND ADDITIONAL PRESSURE, BOTH BREAKING THE CAGE AND BENDING THE TITANIUM JACKET. WHEN THE SURGEON DEEMED THE IMPLANT WAS DAMAGED, A HYBRID PLATE AND SCREWS WERE IMPLANTED OVER THE CONSTRUCT AT THE SAME LEVEL (C4-C5) IN ORDER TO ENSURE ACHIEVED PROPER FIXATION OF THE SEGMENT AND A SUCCESSFUL FUSION AT THE CORRECT SURGICAL LEVEL. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON WAS CONCERNED ABOUT THE STIFFNESS OF THE CONNECTION BETWEEN THE IMPLANT AND THE INSERTER. HOWEVER, UPON FOLLOW UP,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242123 ↗