FlareHawk CMP-00114Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810004723542), received between Mar 15, 2021 and Mar 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

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

• InjuryMar 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POSTERIOR MIGRATION OF THE INNER COMPONENT FROM THE IMPLANTED CONSTRUCT APPROXIMATELY SEVEN (7) WEEKS LATER. INFORMATION PROVIDED BY THE REPRESENTATIVE CONFIRMED THAT THE CONSTRUCT WAS NOT LOCKED DURING THE INITIAL IMPLANTATION BUT WAS RETAINED DUE TO PATIENT ANATOMICAL REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484766 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS APPROXIMATELY SIX (6) WEEKS LATER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484705 ↗