MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION DEVICE

Model Number	FHTPCS0030TT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided and given that the parts were not returned, a definitive cause for this failure could not be determined.No lot numbers were provided for the reported devices and a dhr review could not be performed.There is no evidence to suggest that the devices were nonconforming before use and as such no further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.It is noted that the physician attempted to remove the shell and was unsuccessful.It is captured in stm-00012-ec, rev.C that an unlocked implant or implant without a shim should never be left in a patient and the stm cautions that removal of the shim from the implant assembly for any reason requires removal of the shell and replacement with a new shell.Although no patient harms were reported, a complaint where a shell without any shim was left in place has caused or contributed to a serious injury.Therefore, it was determined that this complaint does meet the definition of reportable event and this complaint was updated with the mdr submission.No further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.
Event or Problem Description
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 the shell, all of which were unsuccessful.Unable to remove the shell, dr.(b)(6) chose to leave it implanted in the patient without a shim.Efforts to remove the shell lasted approximately 1 hour and 15 minutes.The removal attempts were performed within the same surgery.No patient injury or additional impact to patient was reported.The correct size was selected for the patient.There were no intentional deviations from outlined surgical technique.Although the surgical technique instructs the user to not leave an unlocked construct in the patient, it occurred in this event out of necessity.The implant was unable to lockout and unable to be removed.It is noted that the patient had a collapsed disc space condition which may have contributed to the event.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: FLAREHAWK INTERBODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: chris mckee ; 354 hiatt drive; palm beach gardens, FL 33418 ; 9014939467
• MDR Report Key: 21145626
• Report Number: 3012797630-2025-00004
• Device Sequence Number: 21115871
• Product Code: MAX
• UDI-Device Identifier: 00810045530208
• UDI-Public: (01)00810045530208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FHTPCS0030TT
• Device Catalogue Number: FHTPCS0030TT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown