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

Model Number	FHPACT0923H
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/3/2024, it was reported to accelus that during a case, a flarehawk 9 cage was implanted but migrated to anterior of vertebral body (vb) during bone graft packing stage.The cage had to be removed and replaced with another resulting in a 180 min (3 hour) delay.The procedure was completed with another of the same device and no other patient harm or impact was reported.The event happened intra-op.It was reported that the surgical technique for the product was utilized and the information provided indicated that the implant was deployed correctly.The event occurred during the bone graft packing stage where the implant construct was repositioned.There is potential for user error to lead to this event if the implant was not sized properly by the user or if during the bone graft packing excessive force is applied.No other harms besides the 3 hour surgical delay were reported, however the implant construct migrating out of the vertebral body could cause a serious injury if it were to recur.The mdr submission shall be updated pending completion of the complaint investigation.
Additional Manufacturer Narrative
Based on the information provided and the engineering analysis.The failure reported was confirmed.The returned part was inspected and based on the investigation results, it's most likely that excessive force caused the damage to the shim and the implant to move anteriorly, therefore the root cause for this would be user error.Based on the dhr review, there was no evidence to suggest that manufacturing issues caused or contributed to the reported issue.No further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: INTERVERTEBRAL BODY 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: lauren kamer ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 19441908
• Report Number: 3012797630-2024-00007
• Device Sequence Number: 18175024
• Product Code: MAX
• UDI-Device Identifier: 00818613021264
• UDI-Public: (01)00818613021264(10)06230011
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K182114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: FHPACT0923H
• Device Catalogue Number: FHPACT0923H
• Device Lot Number: 06230011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FHPAS10023X
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: Asian