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FlareHawk ASY-00034Recalls & reported problems

Integrity Implants Inc. · Shell, Short 25 mm, FlareHawk 9 · Class 2 · Implant

All models of FlareHawk (29)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810004723474), received between Apr 1, 2020 and Mar 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

Device problems

  • Failure to Osseointegrate1
  • Migration1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryMar 17, 2022Migration; Migration

    ON (B)(6) 2022 ACCELUS WAS INFORMED OF A COMPLAINT ON A FLAREHAWK9 IMPLANT. THE ORIGINAL SURGERY WAS A PLIF AT L3/L4 AND TOOK PLACE ON (B)(6) 2021. IT WAS REPORTED THAT DURING A FOLLOW UP VISIT IT WAS CONFIRMED UNDER RADIOGRAPHIC IMAGING THAT THE ENTIRE CONSTRUCT HAD MIGRATED OUT OF THE LEVEL. AS A RESULT, A REVISION SURGERY WAS PERFORMED ON (B)(6)2022 TO REMOVE THE MIGRATED CONSTRUCT. THE LEVEL WAS THEN FILLED WITH ALLOGRAFT AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. NO ADDITIONAL PATIENT HARM WAS REPORTED. THE REMOVED CONSTRUCT WAS DISCARDED AT THE HOSPITAL AND NOT AVAILABLE FOR RETURN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13793639 ↗
  • InjuryApr 1, 2020Failure to Osseointegrate

    THE COMPANY WAS MADE AWARE THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY DUE TO PSEUDARTHROSIS. IT WAS REPORTED THAT DURING THE INDEX SURGERY, FULL IMPLANT DEPLOYMENT DID NOT OCCUR; AND THE SURGEON REMOVED THE SHIM COMPONENT, BUT LEFT THE SHELL COMPONENT IN THE DISC SPACE. DURING THE REVISION SURGERY THE SHELL COMPONENT WAS REMOVED SUCCESSFULLY. THE EXPLANTED SHELL WAS NOT RETURNED TO THE COMPANY FOR EVALUATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 9914565 ↗

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Sources and updates

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