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

Model Number	FHPAS10623X
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery date: (b)(6) 2025 mis tlif l5s1 a revision surgery date: (b)(6) 2025 cage removal, k2m cage reimplanted.Patient had mis tlif surgery done in (b)(6) 2025, and the fh9 cage found unlocked and backout during latest follow-up check, revision surgery performed on (b)(6) 2025.Fh9 was removed and k2m static cage reimplanted.It was reported that there was no delay and no patient impact however a revision surgery was performed and is considered to be patient impact.
Additional Manufacturer Narrative
A complaint was received regarding migration and back-out of an fh9 cage that occurred following a mis tlif procedure performed on (b)(6) 2025 at level l5-s1.The patient subsequently underwent a revision procedure on (b)(6) 2025, during which the fh9 cage was explanted and replaced with a k2m static cage.Initially, it was reported that there was no patient harm or surgical delay; however, because revision surgery was required, this event is considered to have patient impact and is reportable.The complaint devices were not returned for evaluation, preventing direct physical inspection or testing.Post-operative images were reviewed by the director of posterior procedures, who confirmed that the shim was not fully locked into the shell at the time of the original implantation.This condition is consistent with the reported migration event.Per the surgical technique manual (stm-00018 (f), "caution: an unlocked implant or implant without a shim should never be left in a patient." migration is a known risk associated with leaving an unlocked implant in situ.Given the lack of returned product and the available clinical evidence, the most probable root cause is user error, specifically improper engagement of the shim into the shell during initial implantation.It is unlikely that manufacturing or design was an issue since no similar complaints or trends were identified.Based on the information, a definitive root cause could not be determined.We will continue to track and trend.
Event or Problem Description
Primary surgery date: on (b)(6) 2025 mis tlif l5s1 a revision surgery date: on (b)(6) 2025 cage removal, k2m cage reimplanted.Patient had mis tlif surgery done in (b)(6) 2025, and the fh9 cage found unlocked and backout during latest follow-up check, revision surgery performed on (b)(6) 2025.Fh9 was removed and k2m static cage reimplanted.It was reported that there was no delay and no patient impact however a revision surgery was performed and is considered to be patient impact.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS; 354 hiatt drive; palm beach gardens 33418
• Manufacturer Contact: nancy hamilton ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 22500498
• Report Number: 3012797630-2025-00026
• Device Sequence Number: 12878694
• Product Code: MAX
• UDI-Device Identifier: 00810004723535
• UDI-Public: 00810004723535
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FHPAS10623X
• Device Catalogue Number: FHPAS10623X
• Device Lot Number: 01250017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian