Aero-C 48892050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327124675), received between Aug 7, 2017 and Mar 14, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjuryMar 14, 2020Material Deformation; Separation Problem; Material Deformation; Separation Problem

  STRYKER REPRESENTATIVE REPORTED THAT WHEN THE SURGEON MALLETED AN AERO-C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL INTO THE DISC SPACE, THE BLADES WERE OUTSIDE OF THE IMPLANT AND THE IMPLANT BENT. SURGERY WAS COMPLETED WITH A TWO HOUR DELAY.

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

  MAUDE report 9832644 ↗
• MalfunctionOct 30, 2017Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT; THE CUTTER WOULD NOT PENETRATE BONE. IN RESPONSE THE CAGE KEPT GETTING FORCED OUT OF THE DISC SPACE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6989415 ↗
• MalfunctionAug 7, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT; ANCHOR WOULD NOT FULLY INSERT INTO CAGE. BOTH THE GUIDED AND FREEHAND TAMPS WERE IMPACTED FORCEFULLY AGAINST THE PARTIALLY INSERTED ANCHOR, BUT THE ANCHOR WOULD NOT PROGRESS FURTHER. THE END OF THE ANCHOR REMAINS PROUD BY APPROXIMATELY 1-2MM. THERE WAS A SURGICAL DELAY OF 5 MINUTES ASSOCIATED WITH SEVERAL ATTEMPTS TO IMPACT THE ANCHOR USING BOTH TYPES OF TAMPS IN THE SET. THE SURGEON ULTIMATELY DECIDED TO LEAVE THE CAGE WITH THE ANCHOR REMAINING PROUD. FLUOROSCOPIC IMAGE OF IMPLANTED CAGE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6772610 ↗