MAUDE Adverse Event Report: INTEGRITY IMPLANTS FLAREHAWK INTERBODY FUSION DEVICE

Model Number	FHTPCS0030TT
Medical Device Problem Code	Activation Failure (3270)
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 03/18/2025, it was reported that a doctor had initially determined that a flarehawk shim and shell were properly locked.The doctor indicated he heard a loud pop when deploying the shim into the shell.He used the lock gauge, and the guide protruded out the back of the lock gauge.He believed the implant was locked based upon the reading.When he removed the guide pin the threads of the core (part of the shell) were inside the guide pin.Upon subsequent review of the patient x-rays, it is believed that the shim and shell are not locked as intended.There was a delay of 10 minutes.The patient is doing well and will continue to be monitored.
Additional Manufacturer Narrative
L5-s1 - gangavalli determined the implant to be locked, but upon further evaluation it was not locked.There was a delay of 10 minutes.It was believed the implant was locked due to the reading on the lock gauge.The patient is doing well and will continue to be monitored.For the complaint investigation, a dhr, ncmr, and complaint review could not be conducted since the lot number was not provided.However, a labeling review was conducted, according to the labeling review, stm-00019(c), lock gauge.This instrument does not replace fluoroscopic visualization as the primary form of lock confirmation.Lock verification.As the shim is inserted into the shell, a tactile and audible click may be heard when the lock engages.This indicates that the implant is fully deployed.Nevertheless, lock engagement should always be confirmed using fluoroscopy.An engineering analysis could not be performed on the devices since they were not returned.Based on the information provided, the core of the implant failed at some point during deployment and the implant was left in the disc space unlocked.The root cause of the core failure cannot be determined.Based on the report, the lock status of the implant was reviewed post operatively and found to be unlocked.Per stm-00019 (c), "caution: an unlocked implant or implant without a shim should never be left in a patient." no design or manufacturing issues were identified.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 initially determined that a flarehawk shim and shell were properly locked.The doctor indicated he heard a loud pop when deploying the shim into the shell.He used the lock gauge, and the guide protruded out the back of the lock gauge.He believed the implant was locked based upon the reading.When he removed the guide pin the threads of the core (part of the shell) were inside the guide pin.Upon subsequent review of the patient x-rays, it is believed that the shim and shell are not locked as intended.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: 21785645
• Report Number: 3012797630-2025-00017
• Device Sequence Number: 8692896
• 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): 06/08/2025

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: 06/09/2025
• 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