MAUDE Adverse Event Report: INTEGRITY IMPLANTS FLAREHAWK INTERBODY FUSION DEVICE

Model Number	FHTGS000251S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr (b)(6) had a patient that presented to his clinic with acute onset of back pain.An xray taken revealed that the flarehawk cage implanted at l5-s1 had migrated posteriorly and mostly out of the disc space.The patient will be scheduled for surgery to remove the cage.Based on a discussion with dr (b)(6), it is likely that the patient was put into an unusual position during her post-op recovery period.The patient was in a rehab facility and was dealing with significant constipation and once her hips were placed in a hyper flexed position and had an acute onset of back pain.The devices were implanted on (b)(6) 2025.The devices were removed during revision surgery on (b)(6) 2025.
Additional Manufacturer Narrative
Dr (b)(6) had a patient that presented to his clinic with acute onset of back pain.An xray taken revealed that the flarehawk cage implanted at l5-s1 had migrated posteriorly and mostly out of the disc space.The devices were removed during revision surgery on (b)(6) 2025.Based on a discussion with dr (b)(6), it is likely that the patient was put into an unusual position during her postop recovery period.The patient was in a rehab facility and was dealing with significant constipation and was her hips were placed in a hyper flexed position and had an acute onset of back pain.A review of the dhr, ncmr and complaint records did not identify all related records.The labeling review of (b)(4) was performed as it relates to the reported complaint.It was reported that the flarehawk cage had migrated.A discussion with the physician noted the patient was likely put into an unusual position during her postop recovery period.Per (b)(4).Precautions: adequately instruct the patient.Mental or physical impairment, which compromises or prevents a patient's ability to comply with necessary limitations or precautions, may place that patient at a particular risk during postoperative.Postoperative care is important.The patient should be instructed of the limitations of physical activity such as lifting, twisting, or other excessive motions to reduce risk of excessive load bearing on the implant, and that failure to do so may compromise the implant integrity or delay the healing process.The surgeon should instruct the patient on the time frame required prior to returning to full physical activity.An engineering analysis of the returned device found no defects or mechanical failures and the returned implant was found to be locked.Based on the information provided, the implant may have migrated when the patient was put into an unusual position during the postop recovery period.The implant may also migrate when an undersized shim is used.A device problem was excluded and the issue is likely related to user error based on the reported information however a definitive root cause of the implant migration cannot be established.No device or manufacturing issues were identified during the investigation; we will continue to track and trend for related events.
Event or Problem Description
Dr (b)(6) had a patient that presented to his clinic with acute onset of back pain.An xray taken revealed that the flarehawk cage implanted at l5-s1 had migrated posteriorly and mostly out of the disc space.The patient will be scheduled for surgery to remove the cage.Based on a discussion with dr (b)(6), it is likely that the patient was put into an unusual position during her postop recovery period.The patient was in a rehab facility and was dealing with significant constipation and was her hips were placed in a hyper flexed position and had an acute onset of back pain.The devices were implanted on (b)(6) 2025.The devices were removed during revision surgery on (b)(6) 2025.

• 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: 22094605
• Report Number: 3012797630-2025-00022
• Device Sequence Number: 15425217
• Product Code: MAX
• UDI-Device Identifier: 00840200406727
• UDI-Public: 00840200406727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220453
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Device Model Number: FHTGS000251S
• Device Catalogue Number: FHTGS000251S
• Device Lot Number: 09230035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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 Sex: Female
• Patient Ethnicity: Hispanic