FlareHawkRecalls & reported problems across all models

We found 29 models of FlareHawk by Integrity Implants Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2018 and Oct 15, 2025 — classified as 18 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Migration” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FlareHawk problems

FlareHawk models

29 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FlareHawk FHTPCS0026TT

  Intervertebral Fusion Device With Bone Graft, Lumbar
  3 reports
• FlareHawk FHTPCS0030TT

  Intervertebral Fusion Device With Bone Graft, Lumbar
  3 reports
• FlareHawk ASY-00034

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk CMP-00114

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk ASY-00029

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk FHTGCT0925TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk II-1-0120

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk II-1-0173

  Intervertebral Fusion Device With Bone Graft, Lumbar
  2 reports
• FlareHawk CMP-00666

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk CMP-00897

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk CMP-00414

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk CMP-00113

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk CMP-00166

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHPACS0025TT

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHPAS200259S

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTAS100299S

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTAS106299S

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHPACS0025TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHPACT0925TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTACS0029TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk II-1-0454

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk II-1-0455

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk II-1-0447

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk II-1-0388

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTGCS0025TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTGCT0929TTS

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTGS000251S

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk FHTGS106251S

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report
• FlareHawk II-1-0163

  Intervertebral Fusion Device With Bone Graft, Lumbar
  1 report

Recent FlareHawk adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THAT A FLAREHAWK11 LORDOTIC SHELL 25MM FRACTURED IN TWO UPON INSERTION. THE SHELL WAS REMOVED AND A NEW ONE WAS USED. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS AN APPROXIMATE FIVE MINUTE DELAY TO REPLACE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304171 ↗
• MalfunctionSep 5, 2025Activation Problem; Activation Problem

  A CHARGE SHEET WAS SUBMITTED WITH A WASTED SHIM. UPON FOLLOW UP WITH THE REP, IT WAS COMMUNICATED THAT A FLAREHAWK SHELL HAD BEEN IMPLANTED WITHOUT THE SHIM. NO ADDITIONAL INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 08-21-2025: PER REP: THE ONLY INFORMATION I HAVE ON THIS PARTICULAR CASE IS THAT THE SHIM DIDN'T LOCK AND DR LEE OPTED TO FILL THE SHELL WITH A BIOLOGIC AND TREAT THE SHELL-LIKE IT WAS A STATIC TLIF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984520 ↗
• MalfunctionSep 5, 2025Activation Problem; Activation Problem

  A CHARGE SHEET WAS SUBMITTED WITH A WASTED SHIM. UPON FOLLOW UP WITH THE REP, IT WAS COMMUNICATED THAT A FLAREHAWK SHELL HAD BEEN IMPLANTED WITHOUT THE SHIM. NO ADDITIONAL INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 08-21-2025: PER REP: THE ONLY INFORMATION I HAVE ON THIS PARTICULAR CASE IS THAT THE SHIM DIDN'T LOCK AND DR LEE OPTED TO FILL THE SHELL WITH A BIOLOGIC AND TREAT THE SHELL LIKE IT WAS A STATIC TLIF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984487 ↗
• InjuryJul 14, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  PRIMARY SURGERY DATE: (B)(6) 2025 MIS TLIF L5S1 A REVISION SURGERY DATE: (B)(6) 2025 CAGE REMOVAL, K2M CAGE REIMPLANTED. PATIENT HAD MIS TLIF SURGERY DONE IN (B)(6) 2025, AND THE FH9 CAGE FOUND UNLOCKED AND BACKOUT DURING LATEST FOLLOW-UP CHECK, REVISION SURGERY PERFORMED ON (B)(6) 2025. FH9 WAS REMOVED AND K2M STATIC CAGE REIMPLANTED. IT WAS REPORTED THAT THERE WAS NO DELAY AND NO PATIENT IMPACT HOWEVER A REVISION SURGERY WAS PERFORMED AND IS CONSIDERED TO BE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500498 ↗
• 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 ↗
• InjuryMay 28, 2025Migration; Migration

  DR (B)(6) HAD A PATIENT THAT PRESENTED TO HIS CLINIC WITH ACUTE ONSET OF BACK PAIN. AN XRAY TAKEN REVEALED THAT THE FLAREHAWK CAGE IMPLANTED AT L5-S1 HAD MIGRATED POSTERIORLY AND MOSTLY OUT OF THE DISC SPACE. THE PATIENT WILL BE SCHEDULED FOR SURGERY TO REMOVE THE CAGE. BASED ON A DISCUSSION WITH DR (B)(6), IT IS LIKELY THAT THE PATIENT WAS PUT INTO AN UNUSUAL POSITION DURING HER POST-OP RECOVERY PERIOD. THE PATIENT WAS IN A REHAB FACILITY AND WAS DEALING WITH SIGNIFICANT CONSTIPATION AND ONCE HER HIPS WERE PLACED IN A HYPER FLEXED POSITION AND HAD AN ACUTE ONSET OF BACK PAIN. THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE DEVICES WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2025

  Patient problems: Back pain

  MAUDE report 22094605 ↗
• InjuryMay 28, 2025Migration; Migration

  DR (B)(6) HAD A PATIENT THAT PRESENTED TO HIS CLINIC WITH ACUTE ONSET OF BACK PAIN. AN XRAY TAKEN REVEALED THAT THE FLAREHAWK CAGE IMPLANTED AT L5-S1 HAD MIGRATED POSTERIORLY AND MOSTLY OUT OF THE DISC SPACE. THE PATIENT WILL BE SCHEDULED FOR SURGERY TO REMOVE THE CAGE. BASED ON A DISCUSSION WITH DR (B)(6), IT IS LIKELY THAT THE PATIENT WAS PUT INTO AN UNUSUAL POSITION DURING HER POSTOP RECOVERY PERIOD. THE PATIENT WAS IN A REHAB FACILITY AND WAS DEALING WITH SIGNIFICANT CONSTIPATION AND WAS HER HIPS WERE PLACED IN A HYPER FLEXED POSITION AND HAD AN ACUTE ONSET OF BACK PAIN. THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE DEVICES WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2025.

  Patient problems: Back pain

  MAUDE report 22094545 ↗
• MalfunctionApr 7, 2025Activation Failure; Activation Failure

  ON (B)(6) 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 21785650 ↗
• 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 ↗
• MalfunctionMar 27, 2025Break; Break

  ON (B)(6) 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 21707002 ↗
• 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 25, 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 21692293 ↗
• 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 ↗
• MalfunctionFeb 20, 2025Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427198 ↗

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