FlareHawk FHTGCT0929TTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840200406697), received between Oct 30, 2024 and Oct 30, 2024 — 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Activation Failure; Activation Failure

  ON OCT 2ND, ACCELUS WAS MADE AWARE OF AN ISSUE WITH AN IMPLANT. IT WAS REPORTED THAT DURING THE SURGERY THE SURGEON WAS UNABLE TO CONFIRM IMPLANT LOCKING VIA CONTRALATERAL FLUORO. THE LOCK GAUGE DISPLAYED THE IMPLANT WAS LOCKED BUT FLUORO WAS NOT ABLE TO 100% CONFIRM THE IMPLANT WAS LOCKED. DURING A 2 LEVEL REVISION TLIF CASE ON (B)(6), DR. (B)(6) WAS THE SURGEON DOING THE SURGERY. HE HAS TO BE OBSERVED FOR HIS FIRST 5 CASES AS HE IS JUST OUT OF FELLOWSHIP. DR. (B)(6) WAS HIS OBSERVING SURGEON IN THIS CASE. DR. (B)(6) DID THE TLIF/DISC PREP EXPLAINED TO DR. (B)(6) THAT OUR IMPLANT FLAREHAWK SHOULD BE SIZED LINE TO LINE WITH THE SHAVERS INTRODUCED INTO THE DISC SPACE. I ALSO INTERJECTED AND EXPLAINED FOR PROPER SIZING AND LOCKING OF THE IMPLANT, IT'S IMPERATIVE TO NOT OVERSIZE, TO GO BY THE PADDLE SIZERS AS A HEIGHT TRIAL. DR. (B)(6) EXPLAINED HE WANTED MORE HEIGHT AND DID NOT WANT TO INTRODUCE ANOTHER SHAVER HEIGHT. DR. (B)(6) ALSO SUGGESTED THE EXPANDABLE HEIGHT TRIAL, BUT DR. (B)(6) DID NOT WANT TO USE IT. HE TOLD US HE WANTED A 12 MM, 15DEGREE LORDOTIC IMPLANT, 29MM LENGTH. TAYSSIR JOMAA (REP FOR THE SURGEONS) AND I PULLED THE APPROPRIATELY SIZED SHIM AND SHELL FROM THE FH11 STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567568 ↗