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Aero-C 48892076Recalls & reported problems

Stryker Corporation · Cervical Cage · Class 2 · Implant

All models of Aero-C (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327124668), received between Jun 22, 2016 and Mar 1, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break1
  • Device Operates Differently Than Expected1
  • Malposition of Device1
  • Migration1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Pain1
  • Tingling1

Recent adverse event reports

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

  • MalfunctionMar 1, 2019Malposition of Device; Migration; Migration

    IT WAS REPORTED THAT THE CAGE STARTED BACKING OUT POST-OPERATIVELY. IMPLANT IS STILL IN THE PATIENT AND EXPERIENCED SLIGHT PAIN AND SLIGHT TINGLING IN FINGER. PER THE COMMUNICATION WITH SALES REP., X- RAY IMAGE REVIEW WHICH WAS TAKEN (B)(6) 2019 REVEALED THAT CAGE( PIN) HAD NOT BACKED OUT FURTHER. CURRENTLY, NO REVISION SURGERY HAS BEEN PLANNED.

    Patient problems: Pain; Tingling

    MAUDE report 8383672 ↗
  • InjuryJun 22, 2016Break; Device Operates Differently Than Expected

    IT WAS REPORTED THAT; DURING THE CASE, THE SURGEON QUESTIONED WHETHER THE ANCHORS WERE SEATED. THE PATIENT HAD EXTRAORDINARILY HARD BONE. THE CRANAL CASPAR PIN ACTUALLY SHEARED DURING REMOVAL. THE ANCHOR APPEARED TO BE VERY CLOSE TO SHEARED CASPAR PIN. THE NEXT DAY THE ANCHOR WAS COMPLETELY FLOATING. SURGEON REMOVED THE FLOATING ANCHOR AND PLACED AN PLATE OVER TOP. HE ATTEMPTED TO USE AN AWL TO PILOT THE SCREW. THIS WOULD NOT WORK. HE THEN TRIED A DRILL ON HAND AND THEN USING POWER. NEITHER OF THESE WOULD WORK. HE THEN USED A MIDAS TO PILOT THE HOLES. HE DESTROYED A DRILL BIT. FINALLY HE WAS ABLE TO GET A SCREW STARTED WITH THE SECOND BIT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5743135 ↗

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Sources and updates

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