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

Model Number	FHPACT0925TTS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/23/2024, after reaching out to a rep to clarify why a shim and shell were listed as wasted on the charge sheet, the rep had reported that the surgeon took out the shim and left the shell in the patient.Three follow ups have been made with the rep to get the complaint form populated.No complaint form was completed, but a phone call with the rep provided the following information.On a follow up call with the rep, evan gorges, it was reported that the surgeon didn't check a/p before inserting the shim.When they expanded the implant, after the shim had locked into the shell the surgeon determined the construct went too far forward and the surgeon didn't like placement.During the removal, the shim was removed and while trying to use the shell removal tool, the surgeon pulled the shell back to center and noted the shell provided disc height as it was reported the patient had a collapsed disc space and a lordotic shell was used.The surgeon then opted to leave the shell in the patient and used the shell as a static after the surgeon got the shell at the midline.The surgeon had no concerns with patient and he believes the shell is acting as intended and leaving it in was the best course.No delay in surgery was reported.No patient impact was reported.Patient is doing fine.No new information to report since the surgery.
Additional Manufacturer Narrative
Given that the parts were not returned, a physical analysis could not be performed.It was reported that the surgeon pulled the shell back to center and then opted to leave the shell in the patient and used the shell as a static after the surgeon got the shell at the midline.Based on the information provided, the event was caused by user error.Stm-00018, rev.D was reviewed to ensure that it addresses this issue and does not require any updates.No delay in surgery was reported.No patient impact was reported.Patient is doing fine.No new information to report since the surgery and the surgeon had no concerns with patient and he believes the shell is acting as intended and leaving it in was the best course.Based on the results of the investigation there was no evidence to suggest that design or 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: 20194407
• Report Number: 3012797630-2024-00013
• Device Sequence Number: 18026310
• Product Code: MAX
• UDI-Device Identifier: 00810045530918
• UDI-Public: (01)00810045530918(17)290206(10)12230016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/05/2024

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: FHPACT0925TTS
• Device Catalogue Number: FHPACT0925TTS
• Device Lot Number: 12230016
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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: 73 YR
• Patient Sex: Male