MAUDE Adverse Event Report: INTEGRITY IMPLANTS FLAREHAWK INTERBODY FUSION DEVICE

Model Number	FHTPCS0030TT
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported that a doctor had a flarehawk shell that was not able to be locked and ulitmately removed resulting in the shell being left in the patient by itself.The doctor believes the shim and shell got bound up in the tip of the cannula upon initial deployment as the shell was not fully clear of the cannula.He then tried to retract the shim and advance the implant.This resulted in the shell becoming malformed/misaligned with the shim.He removed the shim but was not able to remove the shell.He determined the shell were not going to go anywhere after attempting to remove them unsuccessfully.There was a delay of 10 minutes.The patient is doing well and will continue to be monitored.
Additional Manufacturer Narrative
It was reported the shim and shell got bound up in the tip of the cannula upon initial deployment as the shell was not fully clear of the cannula.The doctor then tried to retract the shim and advance the implant which caused the shell to become malformed/misaligned with the shim.The shim was removed but the shell was left in placed.There was a delay of 10 minutes and there was no impact to patient.The complaint investigation could not identify any related events since the lot number was not provided.However the surgical technique manual was reviewed and provides instructions on how to properly load the construct through the cannula.Stm-00019 (c) states, step 7 caution: an unlocked implant or implant without a shim should never be left in a patient.No design or manufacturing issues were identified.The engineering analysis determined the root cause was failure to ensure the backstraps of the shell are clear of the cannula prior to deployment.As it was reported the shim and shell got bound up in the tip of the cannula upon initial deployment as the shell was not fully clear of the cannula.Per stm-00019 (c) "prior to deployment, be sure the shell's backstraps have fully cleared the tip of the tubular retractor or cannula.The backstraps extend 5mm posteriorly to the posterior tantalum markers.Failure to do so may result in a non-deployment." we will continue to track and trend to identify similar events.
Event or Problem Description
On (b)(6) 2025, it was reported that a doctor had a flarehawk shell that was not able to be locked and ultimately removed.Resulting in the shell being left in the patient by itself.The doctor believes the shim and shell got bound up in the tip of the cannula upon initial deployment as the shell was not fully clear of the cannula.He then tried to retract the shim and advance the implant.This resulted in the shell becoming malformed/misaligned with the shim.He removed the shim but was not able to remove the shell.He determined the shell were not going to go anywhere after attempting to remove them unsuccessfully.There was a delay of 10 minutes.The patient is doing well and will continue to be monitored.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS; 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; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 21785586
• Report Number: 3012797630-2025-00016
• Device Sequence Number: 15622331
• Product Code: MAX
• UDI-Device Identifier: 00810045530208
• UDI-Public: 00810045530208
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/30/2025

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: FHTPCS0030TT
• Device Catalogue Number: FHTPCS0030TT
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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