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

Model Number	FHTPCS0026TT
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Event or Problem Description
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.

• 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, FL 33418 ; 5615293861
• MDR Report Key: 21529667
• Report Number: 3012797630-2025-00008
• Device Sequence Number: 20927322
• Product Code: MAX
• UDI-Device Identifier: 00810045530185
• UDI-Public: 00810045530185
• 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: 2025
• 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): 03/05/2025

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: FHTPCS0026TT
• Device Catalogue Number: FHTPCS0026TT
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/04/2025
• 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 Age: 72 YR
• Patient Sex: Female