MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM BONE FUNNEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	ASY-00133
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Paresis (1998); Numbness (2415)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The parts were not returned, no analysis could be performed.Not enough information was provided to accurately assess the potential failure mode.Complications with the bone funnel were reported because the bone graft had large granule size and became stuck in the fh7 bone funnel.It is possible that excess force was used to displace the large chunks, causing complications.It is not clear weather or not the graft material was inadequately hydrated or if the granule size was too large for the fh7 bone funnel.No ncmrs or complaints were found that identified a trend, and labeling instructions were found to be adequate.Based on the dhr reviews, there is no evidence to suggest that the devices were nonconforming before use and as such no further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.
Event or Problem Description
On (b)(6), accelus was made aware of an event when dr.(b)(6) informed us that they were needing to perform surgical intervention from a case on (b)(6)2024.The patient had a tlif using flarehawk7.The surgeon said they were needing to revise the case due to l5 paresis.He said that bone chips were blocking the foramen.He reported having trouble with the bone funnel because the bone graft had big chunks so they got stuck in the fh7 bone funnel.Thus, the complaint is alleging an issue with graft delivery through the tamp and funnel and there was no alleged issue with the implants from the case.On (b)(6), additional information was provided after speaking with dr.(b)(6), he reported that the patient's revision went fine and the patient was doing well.No additional information was able to be provided for the devices involved.At the revision, they took all the bone graft that was misplaced.Patient had much better control yesterday but still with numbness in a tolerable radicular pain (in regression).

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM BONE FUNNEL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: chris mckee ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 21123962
• Report Number: 3012797630-2025-00001
• Device Sequence Number: 20698844
• Product Code: LXH
• UDI-Device Identifier: 00810004721890
• UDI-Public: (01)00810004721890(10)04210007
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: ASY-00133
• Device Catalogue Number: ASY-00133
• Device Lot Number: 04210007
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASY-00132 REPEATER BONE TAMP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown