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

Model Number	FHTAS106299S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical case, (b)(6) contacted me (b)(6) 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.(b)(6) 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.
Event or Problem Description
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 end there was no reported patient impact and the surgery was completed by leaving the shell in place and removing the shim.Clarification was obtained during the complaint meeting on monday (b)(6) 2025, the guide pin did not break but the core of the shell broke off inside the guide pin and there was no impact to patient.
Additional Manufacturer Narrative
The device was not returned and therefore could not be assessed.Based on the information provided, the neck of the core failed prior to implant lock was achieved.Based on the provided image, the shell is misaligned relative to the disc space and shim.This likely caused increased insertion forces and led to the core failure.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: nancy hamilton ; 354 hiatt drive; suite 100; palm beach gardens 33418 ; 5615293861
• MDR Report Key: 22216481
• Report Number: 3012797630-2025-00024
• Device Sequence Number: 15491039
• Product Code: MAX
• UDI-Device Identifier: 00810045530536
• UDI-Public: 00810045530536
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: FHTAS106299S
• Device Catalogue Number: FHTAS106299S
• Device Lot Number: 03240009
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown