FlareHawk CMP-00414Recalls & reported problems
Integrity Implants Inc. · Guide Pin, FlareHawk 7 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00810004721814), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionMar 27, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED TO ACCELUS THAT THE REP RAN INTO AN ISSUE WHILE DEPLOYING A CAGE IN DR. (B)(6) INITIAL TLIF CASE ON (B)(6) 2025. THE REP FOLLOWED SURGICAL TECHNIQUE AND WHEN USING THE EXPANDABLE SHAVER, THEY GOT AN 11MM HEIGHT SO THEY BUILT A 26X11X11 0 DEGREE CAGE. WHILE DEPLOYING THE CAGE, THEY HEARD THE CLICK AS USUAL AND AN IMAGE AFTERWARDS WAS TAKEN SHOWING THE SHIM WAS NOT LOCKED INTO THE SHELL. THE GUIDE PIN MUST HAVE SNAPPED INSTEAD. IT WAS REPORTED THERE WAS NO IMPACT TO PATIENT AND NO DELAY TO THE PROCEDURE. THE SURGEON LEFT THE SHIM IN THE SHELL, PLACED SCREWS AND RODS AND FINISHED THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707002 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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