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

Model Number	FHTACS0029TTS
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided and given that the parts were not returned, a definitive cause for this failure could not be determined.It is possible that the implant selected was too large for the disc space and thus failed to deploy.However, with the information provided this cannot be confirmed.Additionally, based on the results of the investigation there was no evidence to suggest that manufacturing issues caused or contributed to the reported issue.It is noted that the physician attempted to remove the shell and was unsuccessful.It is captured in (b)(4) that an unlocked implant or implant without a shim should never be left in a patient and the stm cautions that removal of the shim from the implant assembly for any reason requires removal of the shell and replacement with a new shell.Although no patient harms were reported, a complaint where a shell without any shim was left in place has caused or contributed to a serious injury.Therefore, it was determined that this complaint does meet the definition of reportable event and this complaint was updated with the mdr submission.No further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.
Event or Problem Description
On sep 7th, it was reported to accelus, that during a case, the implant failed to deploy.The surgeon tried multiple times to adjust the cage, with the inserter and used the checker but it still read as unlocked.He wanted to replace the cage with a smaller cage.The doctor didn't want to collapse the cage since it was 95% expanded but couldn't get the last 1-2mm to lock position.Then went ahead to remove the shim with the removal tool, which came out.The went to use the shell removal tool and it broke the shell.Then tried to remove it with a new guide pin to try to pull out the shell.Then used pituitary to try to remove the shell but was unsuccessful.Shell did not come out, it remained, and the doctor added additional bone graft.No patient harm was reported as a result of this issue.A 30-minute procedural delay was reported when the complaint entry form was completed and submitted on 18 oct 2023.

• 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: 21145384
• Report Number: 3012797630-2025-00003
• Device Sequence Number: 9262696
• Product Code: MAX
• UDI-Device Identifier: 00810045530925
• UDI-Public: (01)00810045530925(17)280116(10)12220014(240)FHTACS0029TTS
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: FHTACS0029TTS
• Device Catalogue Number: FHTACS0029TTS
• Device Lot Number: 12220014
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male