FlareHawk FHTACS0029TTSRecalls & reported problems
Integrity Implants Inc. · Shell, Short 29 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 00810045530925), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
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.
MalfunctionJan 13, 2025Activation Failure; Activation Failure
ON SEP 7TH, IT WAS REPORTED TO ACCELUS, THAT DURING A CASE, THE IMPLANT FAILED TO DEPLOY. THE SURGEON TRIED MULTIPLE TIMES TO ADJUST THE CAGE, WITH THE INSERTER AND USED THE CHECKER BUT IT STILL READ AS UNLOCKED. HE WANTED TO REPLACE THE CAGE WITH A SMALLER CAGE. THE DOCTOR DIDN'T WANT TO COLLAPSE THE CAGE SINCE IT WAS 95% EXPANDED BUT COULDN'T GET THE LAST 1-2MM TO LOCK POSITION. THEN WENT AHEAD TO REMOVE THE SHIM WITH THE REMOVAL TOOL, WHICH CAME OUT. THE WENT TO USE THE SHELL REMOVAL TOOL AND IT BROKE THE SHELL. THEN TRIED TO REMOVE IT WITH A NEW GUIDE PIN TO TRY TO PULL OUT THE SHELL. THEN USED PITUITARY TO TRY TO REMOVE THE SHELL BUT WAS UNSUCCESSFUL. SHELL DID NOT COME OUT, IT REMAINED, AND THE DOCTOR ADDED ADDITIONAL BONE GRAFT. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE. A 30-MINUTE PROCEDURAL DELAY WAS REPORTED WHEN THE COMPLAINT ENTRY FORM WAS COMPLETED AND SUBMITTED ON 18 OCT 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21145384 ↗
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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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