MAUDE Adverse Event Report: Axogen Corporation Axoguard HA+ Nerve Protector; Nerve Cuff

Model Number	AGHA36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Impaired Healing (2378)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury

• 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
• MDR Report Key: 50904113
• Report Number: 3017860045-2026-00017
• Device Sequence Number: 12271408
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: (01)10850828007135(17)270318(30)1(10)LB1700653
• 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: 2026
• 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): 09/25/2026

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 Model Number: AGHA36
• Device Lot Number: LB1700653
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: 47 YR
• Patient Sex: Female