FlareHawk CMP-00113Recalls & reported problems
Integrity Implants Inc. · Shim, 10mm or 12mm x 25 mm, 6 degree, FlareHawk 9 · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004723535), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.
Reports received per month
Most reported problems
Device problems
- Migration or Expulsion of Device1
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.
InjuryJul 14, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
PRIMARY SURGERY DATE: (B)(6) 2025 MIS TLIF L5S1 A REVISION SURGERY DATE: (B)(6) 2025 CAGE REMOVAL, K2M CAGE REIMPLANTED. PATIENT HAD MIS TLIF SURGERY DONE IN (B)(6) 2025, AND THE FH9 CAGE FOUND UNLOCKED AND BACKOUT DURING LATEST FOLLOW-UP CHECK, REVISION SURGERY PERFORMED ON (B)(6) 2025. FH9 WAS REMOVED AND K2M STATIC CAGE REIMPLANTED. IT WAS REPORTED THAT THERE WAS NO DELAY AND NO PATIENT IMPACT HOWEVER A REVISION SURGERY WAS PERFORMED AND IS CONSIDERED TO BE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22500498 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.