FlareHawk FHTPCS0030TTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810045530208), received between Jan 13, 2025 and Apr 7, 2025 — classified as 3 malfunctions.

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 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.

• MalfunctionApr 7, 2025Activation Failure; Activation Failure

  ON 03/18/2025, IT WAS REPORTED THAT A DOCTOR HAD INITIALLY DETERMINED THAT A FLAREHAWK SHIM AND SHELL WERE PROPERLY LOCKED. THE DOCTOR INDICATED HE HEARD A LOUD POP WHEN DEPLOYING THE SHIM INTO THE SHELL. HE USED THE LOCK GAUGE, AND THE GUIDE PROTRUDED OUT THE BACK OF THE LOCK GAUGE. HE BELIEVED THE IMPLANT WAS LOCKED BASED UPON THE READING. WHEN HE REMOVED THE GUIDE PIN THE THREADS OF THE CORE (PART OF THE SHELL) WERE INSIDE THE GUIDE PIN. UPON SUBSEQUENT REVIEW OF THE PATIENT X-RAYS, IT IS BELIEVED THAT THE SHIM AND SHELL ARE NOT LOCKED AS INTENDED. THERE WAS A DELAY OF 10 MINUTES. THE PATIENT IS DOING WELL AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785645 ↗
• MalfunctionApr 7, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, IT WAS REPORTED THAT A DOCTOR HAD A FLAREHAWK SHELL THAT WAS NOT ABLE TO BE LOCKED AND ULTIMATELY REMOVED. RESULTING IN THE SHELL BEING LEFT IN THE PATIENT BY ITSELF. THE DOCTOR BELIEVES THE SHIM AND SHELL GOT BOUND UP IN THE TIP OF THE CANNULA UPON INITIAL DEPLOYMENT AS THE SHELL WAS NOT FULLY CLEAR OF THE CANNULA. HE THEN TRIED TO RETRACT THE SHIM AND ADVANCE THE IMPLANT. THIS RESULTED IN THE SHELL BECOMING MALFORMED/MISALIGNED WITH THE SHIM. HE REMOVED THE SHIM BUT WAS NOT ABLE TO REMOVE THE SHELL. HE DETERMINED THE SHELL WERE NOT GOING TO GO ANYWHERE AFTER ATTEMPTING TO REMOVE THEM UNSUCCESSFULLY. THERE WAS A DELAY OF 10 MINUTES. THE PATIENT IS DOING WELL AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785586 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 4/3/2024, IT WAS REPORTED TO ACCELUS THAT DR. (B)(6) PERFORMED AN L2/3 PERCUTANEOUS TLIF UTILIZING THE FLAREHAWK7 MIS UNIVERSAL SYSTEM. HE PLACED THE CANNULA IN THE DISC SPACE AND PERFORMED A DISCECTOMY USING THE FH7 PROVIDED INSTRUMENTATION. UTILIZING THE 8MM SHAVER THROUGH THE CANNULA, HE WAS ABLE TO TURN THE 8MM-PADDLE SHAVER. HE SELECTED AN 8MM FLAREHAWK7 30MM 0-DEGREE IMPLANT AS THE FINAL IMPLANT CONSTRUCT SIZE. HE DID NOT PREPACK BONE GRAFT. THE IMPLANT WAS PLACED IN THE DISC SPACE WITH THE INSERTION INSTRUMENT. DURING EXPANSION OF THE IMPLANT, A LOUD POP WAS HEARD IN THE ROOM. THE GUIDE PIN HAD SHEARED OFF THE IMPLANT. DR. (B)(6) TOOK A CONTRALATERAL OBLIQUE X-RAY, NOTING THAT THE IMPLANT WAS NOT LOCKED. HE THEN FOLLOWED THE STEPS OUTLINED IN THE SURGICAL TECHNIQUE FOR REMOVAL OF THE FLAREHAWK7 IMPLANT. THE REMOVAL DILATORS WERE PLACED, AND THE SHIM WAS REMOVED WITH THE SHIM REMOVAL TOOL. DR. (B)(6) ATTEMPTED TO REMOVE THE SHELL WITH THE SHELL REMOVAL TOOL BUT WAS UNSUCCESSFUL AFTER SEVERAL ATTEMPTS TO GRASP THE FLEXORS OF THE CAGE. THE SHELL REMOVAL TOOL WOULD NOT GRASP THE FLEXORS OF THE IMPLANT AS THE DEVICE INTENDS TO DO. HE TRIED USING OTHER CANNULA OPTIONS TO REACH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145626 ↗