Aero-C 48892066Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327124651), received between Mar 9, 2016 and Jun 9, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE FIRST OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971307 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE THIRD OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971273 ↗
• MalfunctionJun 9, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT PLACEMENT, THE BLADES OF THREE AERO C CAGES WERE NOT ENGAGING PROPERLY. AT C5/6 THE BLADES OF TWO CAGES WOULD NOT SEAR, AND AT C6/7 THE SUPERIOR BLADE PLUNGED DEEPER THAN EXPECTED. ALL THREE CAGES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATIVELY AVAILABLE IMPLANTS. THIS RECORD CAPTURES THE SECOND OF THE THREE CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971190 ↗
• MalfunctionJun 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN AERO C CAGE ANCHOR DISENGAGED INTRA-OPERATIVELY. AN X-RAY WAS TAKEN DURING THE PROCEDURE TO CONFIRM THE POSITION OF THE AERO-C ANCHOR AND IT WAS DISCOVERED THAT THE ANCHOR WAS IMPLANTED BEYOND THE POSTERIOR END OF THE AERO C CAGE. THE CAGE AND THE ANCHOR WERE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ALTERNATE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10182033 ↗
• MalfunctionJun 30, 2017Mechanical Problem; Mechanical Problem; Migration or Expulsion of Device; Retraction Problem

  IT WAS REPORTED THAT; THE BLADE WOULD NOT GO INTO THE BODY AND CAGE KEPT MIGRATING INTERIORLY. CAGE WAS LEFT IMPLANTED VERY ANTERIOR AND HAD TO USE EXCESSIVE MALLETING. 2 ANCHORS WERE IMPLANTED. AFTER EXCESSIVE FORCE THE BLADE WAS FINALLY IMPLANTED. ADVERSE CONSEQUENCES REMAINS TO BE SEEN. PATIENT HAD HARD BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681579 ↗
• MalfunctionFeb 3, 2017Detachment Of Device Component; Mechanical Problem; Device Slipped; Device Operates Differently Than Expected; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT; USING AN IMPLANT TODAY FOR A CERVICAL FUSION, ONE OF THE ANCHORS WENT THROUGH THE STOP FEATURE THAT PREVENTS THE ANCHOR FROM MIGRATING POSTERIORLY, THE DOCTOR LEFT AS IS, NO REPLACEMENT DEVICE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301226 ↗
• InjuryAug 25, 2016Device Slipped; Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE BLADE FROM CAME OUT OF THE IMPLANT AND WAS RESTING CLOSE TO THE PATIENT'S ESOPHAGUS.

  Patient problems: Injury; No Information

  MAUDE report 5903384 ↗
• MalfunctionJun 3, 2016Migration or Expulsion of Device; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE IMPACTING THE SUPERIOR BLADE OF THE CAGE, IT WAS BEING PUSHED POSTERIORLY. AT THE TIME THE BLADE LOCKED INTO THE CAGE, THE POSTERIOR PORTION OF THE CAGE WAS NOT FLUSH W/ THE VERTEBERBRAL BODY, AS IT WAS WHEN THE PUNCH AWLS WERE ALL THE WAY IMPACTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5699055 ↗
• MalfunctionMar 9, 2016Mechanical Jam; Failure to Advance; Mechanical Jam

  IT WAS REPORTED THAT DURING THE INSERTION OF THE IMPLANT, THE BLADE/ ANCHOR WOULD NOT ADVANCE. THE SURGEON WAS FORCIBLY MALLETING THE ANCHOR TAMP AND THE BLADE WOULD NOT ADVANCE INTO THE SUPERIOR VERTEBRAL BODY (C5). THE ENTIRE DEVICE HAD TO BE REMOVED USING THE REMOVAL TOOL AND AN ALTERNATE DEVICE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5489814 ↗