FlareHawk FHPACT0925TTSRecalls & reported problems
Integrity Implants Inc. · Shell, Lordotic 25 mm, TiH9 Sterile · Class 2 · Implant
All models of FlareHawk (29)
Data updated Oct 18, 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 00810045530918), received between Sep 11, 2024 and Sep 11, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
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.
MalfunctionSep 11, 2024Migration; Migration
ON 08/23/2024, AFTER REACHING OUT TO A REP TO CLARIFY WHY A SHIM AND SHELL WERE LISTED AS WASTED ON THE CHARGE SHEET, THE REP HAD REPORTED THAT THE SURGEON TOOK OUT THE SHIM AND LEFT THE SHELL IN THE PATIENT. THREE FOLLOW UPS HAVE BEEN MADE WITH THE REP TO GET THE COMPLAINT FORM POPULATED. NO COMPLAINT FORM WAS COMPLETED, BUT A PHONE CALL WITH THE REP PROVIDED THE FOLLOWING INFORMATION. ON A FOLLOW UP CALL WITH THE REP, EVAN GORGES, IT WAS REPORTED THAT THE SURGEON DIDN'T CHECK A/P BEFORE INSERTING THE SHIM. WHEN THEY EXPANDED THE IMPLANT, AFTER THE SHIM HAD LOCKED INTO THE SHELL THE SURGEON DETERMINED THE CONSTRUCT WENT TOO FAR FORWARD AND THE SURGEON DIDN'T LIKE PLACEMENT. DURING THE REMOVAL, THE SHIM WAS REMOVED AND WHILE TRYING TO USE THE SHELL REMOVAL TOOL, THE SURGEON PULLED THE SHELL BACK TO CENTER AND NOTED THE SHELL PROVIDED DISC HEIGHT AS IT WAS REPORTED THE PATIENT HAD A COLLAPSED DISC SPACE AND A LORDOTIC SHELL WAS USED. THE SURGEON THEN OPTED TO LEAVE THE SHELL IN THE PATIENT AND USED THE SHELL AS A STATIC AFTER THE SURGEON GOT THE SHELL AT THE MIDLINE. THE SURGEON HAD NO CONCERNS WITH PATIENT AND HE BELIEVES THE SHELL IS ACTING AS INTENDED AND LEAVING IT IN WAS THE BE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20194407 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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