FlareHawk FHTAS106299SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810045530536), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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.

• MalfunctionJun 16, 2025Malposition of Device; Malposition of Device

  DURING A SURGICAL CASE, VINCENT FRAZIER CONTACTED ME (HEATHER CAIN) INTRAOPERATIVELY TO REVIEW AN IMAGE OF AN IMPLANTED DEVICE AND TO CONFIRM WHETHER THE IMPLANT WAS PROPERLY LOCKED. UPON REVIEWING THE IMAGE, I NOTED THAT THE IMPLANT WAS NOT LOCKED AND APPEARED TO BE ROTATED. VINCENT COMMUNICATED THAT THE GUIDE PIN HAD BROKEN OFF DURING THE EXPANSION PHASE. I ADVISED THE TEAM TO ATTEMPT LOCKING THE IMPLANT. THE SURGEON PROCEEDED BY PLACING THE LOCK GAUGE INTO THE POSTERIOR ASPECT OF THE IMPLANT AND MALLETING THE BACK OF THE SHIM TO SECURE IT WITHIN THE SHELL. DESPITE THESE EFFORTS, SUBSEQUENT IMAGES CONFIRMED THAT THE IMPLANT REMAINED UNLOCKED. GIVEN THE ROTATION AND FAILURE TO LOCK, I RECOMMENDED REMOVING THE IMPLANT. THE SURGICAL TEAM WAS ABLE TO SUCCESSFULLY EXTRACT THE SHIM USING THE SHIM REMOVAL TOOL. HOWEVER, THE SURGEON DETERMINED THAT IT WOULD BE SAFER TO LEAVE THE SHELL IN PLACE AND NOT ATTEMPT REMOVAL. IT WAS ALSO NOTED THAT THE SURGEON HAD SHAVED THE VERTEBRAL BODY DOWN TO 11 MM IN HEIGHT AND WAS ATTEMPTING TO PLACE A 10 MM IMPLANT. THERE WAS A 30 MINUTE DELAY. IT WAS REPORTED IN THE COMPLAINT AS YES THERE WAS IMPACT TO PATIENT BECAUSE OF THE 30 MINUTE DELAY BUT IN THE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216481 ↗