FlareHawk FHTGCT0925TTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840200406642), received between May 28, 2025 and Oct 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THAT A FLAREHAWK11 LORDOTIC SHELL 25MM FRACTURED IN TWO UPON INSERTION. THE SHELL WAS REMOVED AND A NEW ONE WAS USED. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS AN APPROXIMATE FIVE MINUTE DELAY TO REPLACE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304171 ↗
• InjuryMay 28, 2025Migration; Migration

  DR (B)(6) HAD A PATIENT THAT PRESENTED TO HIS CLINIC WITH ACUTE ONSET OF BACK PAIN. AN XRAY TAKEN REVEALED THAT THE FLAREHAWK CAGE IMPLANTED AT L5-S1 HAD MIGRATED POSTERIORLY AND MOSTLY OUT OF THE DISC SPACE. THE PATIENT WILL BE SCHEDULED FOR SURGERY TO REMOVE THE CAGE. BASED ON A DISCUSSION WITH DR (B)(6), IT IS LIKELY THAT THE PATIENT WAS PUT INTO AN UNUSUAL POSITION DURING HER POSTOP RECOVERY PERIOD. THE PATIENT WAS IN A REHAB FACILITY AND WAS DEALING WITH SIGNIFICANT CONSTIPATION AND WAS HER HIPS WERE PLACED IN A HYPER FLEXED POSITION AND HAD AN ACUTE ONSET OF BACK PAIN. THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE DEVICES WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2025.

  Patient problems: Back pain

  MAUDE report 22094545 ↗