FlareHawk ASY-00029Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818613021264), received between Dec 16, 2020 and Jun 1, 2024 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionJun 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ON 5/3/2024, IT WAS REPORTED TO ACCELUS THAT DURING A CASE, A FLAREHAWK 9 CAGE WAS IMPLANTED BUT MIGRATED TO ANTERIOR OF VERTEBRAL BODY (VB) DURING BONE GRAFT PACKING STAGE. THE CAGE HAD TO BE REMOVED AND REPLACED WITH ANOTHER RESULTING IN A 180 MIN (3 HOUR) DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO OTHER PATIENT HARM OR IMPACT WAS REPORTED. THE EVENT HAPPENED INTRA-OP. IT WAS REPORTED THAT THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED AND THE INFORMATION PROVIDED INDICATED THAT THE IMPLANT WAS DEPLOYED CORRECTLY. THE EVENT OCCURRED DURING THE BONE GRAFT PACKING STAGE WHERE THE IMPLANT CONSTRUCT WAS REPOSITIONED. THERE IS POTENTIAL FOR USER ERROR TO LEAD TO THIS EVENT IF THE IMPLANT WAS NOT SIZED PROPERLY BY THE USER OR IF DURING THE BONE GRAFT PACKING EXCESSIVE FORCE IS APPLIED. NO OTHER HARMS BESIDES THE 3 HOUR SURGICAL DELAY WERE REPORTED, HOWEVER THE IMPLANT CONSTRUCT MIGRATING OUT OF THE VERTEBRAL BODY COULD CAUSE A SERIOUS INJURY IF IT WERE TO RECUR. THE MDR SUBMISSION SHALL BE UPDATED PENDING COMPLETION OF THE COMPLAINT INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441908 ↗
• MalfunctionDec 16, 2020Migration; Migration

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT NO SERIOUS INJURY OCCURRED AS WAS INITIALLY REPORTED AS A RESULT OF THIS PRODUCT COMPLAINT. THERE WAS NO REPORTED SURGICAL DELAY, DEATH OR SERIOUS ILLNESS OR INJURY ASSOCIATED WITH THIS COMPLAINT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023116 ↗