FlareHawk FHTPCS0026TTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810045530185), received between Jan 13, 2025 and Mar 27, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Activation Problem; Activation Problem

  ON 2/25/2025, IT WAS REPORTED TO ACCELUS THAT THE REP RAN INTO AN ISSUE WHILE DEPLOYING A CAGE IN DR. (B)(6) INITIAL TLIF CASE ON (B)(6) 2025. THE REP FOLLOWED SURGICAL TECHNIQUE AND WHEN USING THE EXPANDABLE SHAVER, THEY GOT AN 11MM HEIGHT SO THEY BUILT A 26X11X11 0 DEGREE CAGE. WHILE DEPLOYING THE CAGE, THEY HEARD THE CLICK AS USUAL AND AN IMAGE AFTERWARDS WAS TAKEN SHOWING THE SHIM WAS NOT LOCKED INTO THE SHELL. THE GUIDE PIN MUST HAVE SNAPPED INSTEAD. IT WAS REPORTED THERE WAS NO IMPACT TO PATIENT AND NO DELAY TO THE PROCEDURE. THE SURGEON LEFT THE SHIM IN THE SHELL, PLACED SCREWS AND RODS AND FINISHED THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706908 ↗
• MalfunctionMar 5, 2025Malposition of Device; Malposition of Device

  AFTER FOLLOWING UP ON A WASTED IMPLANT, IT WAS REPORTED THE SHELL WAS MISALIGNED/TWISTED DURING SHIM INSERTION AND DEFORMED CAUSING IT TO NOT LOCK. THE SHIM WAS RETRIEVED (REMOVED AND DISCARDED) BUT SHELL WAS DETERMINED BY THE PHYSICIAN TO BE DEPLOYED IN A SAFE MANNER, SO IT WAS NOT REMOVED AND LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529667 ↗
• MalfunctionJan 13, 2025Fracture; Fracture

  ON 08APR2022, ACCELLUS WAS MADE AWARE OF A COMPLAINT REGARDING A GUIDE PIN WHICH, DURING A PROCEDURE, WOULD NOT ADHERE TO THE SHIM AND SHELL. AFTER MULTIPLE ATTEMPTS TO REATTACH A NEW GUIDE PIN THROUGH THE SHIM AND ONTO THE CORE OF THE SHELL, IT WAS DETERMINED THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE IMPLANT PRIOR TO REACHING FULL EXPANSION. SHIM REMOVAL TOOL WAS USED TO REMOVE SHIM, SHELL REMOVAL TOOL WAS USED TO REVERSE SHELL BACK A FEW MILLIMETERS, THEN SHELL WAS PLACED IN MIDLINE POSITION AND PACKED WITH BONE GRAFT, THEN PEDICLE SCREWS WERE PLACED. THERE WAS NO HARM TO THE PATIENT REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144127 ↗