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FlareHawk CMP-00166Recalls & reported problems

Integrity Implants Inc. · Shim, 8mm or 11mm x 29 mm, 0 degree, FlareHawk 9 · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004723597), received between Feb 3, 2021 and Feb 3, 2021 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 3, 2021Migration; Migration

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. SUBSEQUENTLY, POST-OPERATIVE IMAGING IDENTIFIED POSTERIOR MIGRATION OF THE INNER COMPONENT FROM THE IMPLANTED CONSTRUCT APPROXIMATELY SEVEN WEEKS LATER. THE PATIENT HAS NOT UNDERGONE A REVISION AT THIS TIME, AS THE SURGEON INTENDS TO MONITOR THE PATIENT TO DETERMINE IF A REVISION WOULD BE NECESSARY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11272256 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.