FlareHawk FHTGS000251SRecalls & reported problems
Integrity Implants Inc. · Shim, 7 mm or 10 mm x 23 mm/ 25 mm, 0 degree, FH11 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840200406727), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
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
- Back pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Migration; Migration
DR (B)(6) HAD A PATIENT THAT PRESENTED TO HIS CLINIC WITH ACUTE ONSET OF BACK PAIN. AN XRAY TAKEN REVEALED THAT THE FLAREHAWK CAGE IMPLANTED AT L5-S1 HAD MIGRATED POSTERIORLY AND MOSTLY OUT OF THE DISC SPACE. THE PATIENT WILL BE SCHEDULED FOR SURGERY TO REMOVE THE CAGE. BASED ON A DISCUSSION WITH DR (B)(6), IT IS LIKELY THAT THE PATIENT WAS PUT INTO AN UNUSUAL POSITION DURING HER POST-OP RECOVERY PERIOD. THE PATIENT WAS IN A REHAB FACILITY AND WAS DEALING WITH SIGNIFICANT CONSTIPATION AND ONCE HER HIPS WERE PLACED IN A HYPER FLEXED POSITION AND HAD AN ACUTE ONSET OF BACK PAIN. THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE DEVICES WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2025
Patient problems: Back pain
MAUDE report 22094605 ↗
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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 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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