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Aero-C 48896066Recalls & reported problems

Stryker Corporation · Cervical Cage · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327124842), received between May 9, 2016 and Jun 4, 2021 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1
  • Migration1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 4, 2021Migration; Migration

    IT WAS REPORTED THAT AN AERO-C PEEK CAGE AT C3/4 MIGRATED POST-OPERATIVELY. FUSION HAS BEEN ACHIEVED. REVISION SURGERY IS NOT SCHEDULED OR PLANNED AT THIS TIME.

    Patient problems: Pain

    MAUDE report 11939187 ↗
  • MalfunctionMay 9, 2016Device Dislodged or Dislocated

    IT WAS REPORTED THAT; HARD BONE CAUSED ALMOST THE ENTIRE CAGE TO BACK OUT OF THE SPACE UPON IMPACTING THE FIRST ANCHOR. SO MUCH SO THAT THE ANCHOR FULLY LOCKED INTO THE CAGE BUT THE CAGE WAS HANGING OUT OF THE DISC SPACE BY OVER 50%. REMOVED AND USED PLATE/PEEK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5640871 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.