FlareHawk FHTAS100299SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810045530499), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2023Migration; Migration

  ON (B)(6) 2023 ACCELUS WAS INFORMED OF A REVISION SURGERY TO REMOVE AN UNLOCKED FLAREHAWK 9 SHIM FROM A TIHAWK 9 IMPLANTED CAGE. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2023. IT WAS LATER REPORTED THAT THE SHIM WAS UNLOCKED AND MIGRATING FROM THE SHELL. DURING THE REVISION PROCEDURE ON (B)(6) 2023, THE SURGEON MADE INCISION ON LEFT SIDE OF PATIENT AND DISSECTED DOWN TO THE L5-S1 POSTERIOR JOINT ON LEFT SIDE OF PATIENT. RETRACTION OF THE TISSUE WAS PERFORMED OVER LEFT SIDE L5-S1. THE SURGEON THEN REMOVED THE SHIM WITH THE USE OF PITUITARIES. THE SURGEON WAS ADVISED BY VINCENT FRAZIER (SALES REP) TO REMOVE THE SHELL PER THE SURGICAL TECHNIQUE MANUAL; HOWEVER, THEY CHOSE TO LEAVE THE SHELL IN PLACE AT L5-S1. IN-DEPTH ASSESSMENT OF EXITING NERVE ROOTS AND SPINAL WERE DONE, THE PROCEDURE WAS THEN COMPLETED WITHOUT ISSUE. REPORTEDLY, THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS AS A RESULT OF THE MIGRATED SHIM. NO ADDITIONAL PATIENT HARM WAS REPORTED DURING THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007440 ↗