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

Model Number	CMP-00414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The devices were not returned therefore an engineering analysis could not be conducted for the physical parts, therefore, no root cause could be determined.However, the surgeon was aware the implant was not locked and chose to leave it in the disc space.It was reported that an image was taken but the image was not provided to integrity implants to confirm the unlocked/locked construct.As noted previously, per stm-00019 (c) "an unlocked implant or implant without a shim should never be left in a patient.".
Event or Problem Description
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.

• 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 INC.; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: nancy hamilton ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 21707002
• Report Number: 3012797630-2025-00015
• Device Sequence Number: 15970480
• Product Code: MAX
• UDI-Device Identifier: 00810004721814
• UDI-Public: 00810004721814
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: CMP-00414
• Device Catalogue Number: FHTPGP1A
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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
• Patient Sex: Unknown