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

Model Number	FHPAS200259S
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Accelus was notified that a patient who underwent a mis tlif on (b)(6) 2024, recently had a post-op x ray taken that showed thar a shim was not locked to the shell and has moved posteriorly toward the spinal canal.The rep stated that during the case, they checked it twice and the guide pin was flush with the checker which indicated that it was "locked".It was also noted that x-ray images were reviewed during the case.No revision planned at this time.The patient has not reported pain or discomfort to date.
Additional Manufacturer Narrative
Although the parts were not returned and no physical engineering analysis could be performed, based on the information and images provided, it appears the shim was not initially locked in the shell.Therefore, the complaint can be confirmed that the implant was not locked, therefore, the root can be attributed to user error.Stm-00018, rev.D was reviewed to ensure that it addresses this issue and does not require any updates.Furthermore, based on the results of the investigation there was no evidence to suggest that manufacturing issues caused or contributed to the reported issue.No further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.

• 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: 19833178
• Report Number: 3012797630-2024-00009
• Device Sequence Number: 7421220
• Product Code: MAX
• UDI-Device Identifier: 00810045530437
• UDI-Public: (01)00810045530437(17)270927(10)07220038(240)FHPAS200259S
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: FHPAS200259S
• Device Catalogue Number: FHPAS200259S
• Device Lot Number: 07220038
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FHPACT0925TTS.
• Patient Sex: Unknown