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

Model Number	FHTGCS0025TTS
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: FLAREHAWK INTERBODY FUSION
• 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; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 22984520
• Report Number: 3012797630-2025-00034
• Device Sequence Number: 9549378
• Product Code: MAX
• UDI-Device Identifier: 00840200406628
• UDI-Public: 00840200406628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FHTGCS0025TTS
• Device Catalogue Number: FHTGCS0025TTS
• Device Lot Number: 02220089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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 Sex: Unknown