MAUDE Adverse Event Report: AXOGEN CORPORATION AXOGUARD HA+ NERVE PROTECTOR; NERVE CUFF

Lot Number	LB1506021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Seroma (2069)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device utilization report was pulled (b)(6) 2026.29 products from this lot were reported implanted.The recall report was pulled (b)(6) 2026.31 devices from this lot were invoiced and sold.There are not other complaints reported for this lot.A review of the device lot history record indicated the device was manufactured to specifications.No nonconformances were identified in devices released for distribution.The lot produced 36 devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.
Event or Problem Description
This is an initial, serious, spontaneous report regarding a female patient (age unknown) who underwent a cubital tunnel revision in which axoguard ha+ nerve protector was implanted on (b)(6) 2024, and subsequently experienced incision site inflammation, implant site pain, and implant site seroma requiring explant.Following implantation, the patient developed localized redness, irritation, and pain at the surgical site.Due to persistent symptoms, the ha+ device was explanted on (b)(6) 2026.

• Brand Name: AXOGUARD HA+ NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; 111 w oak ave; suite 500; tampa FL 33602
• Manufacturer (Section G): EVERGEN; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: rachel thomas ; 111 w oak ave; suite 500; tampa, FL
• MDR Report Key: 25669274
• Report Number: 3017860045-2026-00011
• Device Sequence Number: 13375059
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: (01)10850828007135(17)241116(30)1(10)LB1506021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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 Expiration Date: 11/16/2024
• Device Lot Number: LB1506021
• 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: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2023
• 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