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

Lot Number	LB1598377
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This is an initial, serious, spontaneous report regarding a male patient (age unknown) who underwent a cubital tunnel revision in which axoguard ha+ nerve protector was implanted and subsequently experienced incision site inflammation and implant site pain requiring explant.On (b)(6) 2025, the patient underwent a cubital tunnel revision procedure during which axoguard ha+ nerve protector was implanted.Following implantation, the patient developed localized redness, irritation, and pain at the surgical site.The condition was monitored for a period of time; however, due to persistence of symptoms, the ha+ device was explaned on (b)(6) 2025.
Additional Manufacturer Narrative
The device utilization report was pulled on 08-june-2026.A total of (b)(6) devices reported to be implanted.The recall report was pulled 15-june- 2026.45 devices were invoiced and sold.There were no other reported complaints 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 50 devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.The reported inflammatory symptoms occurred following implantation and led to a subsequent explant; however, insufficient clinical detail is available to determine the underlying cause.Potential contributing factors, including surgical technique, wound healing conditions, and patient-specific factors, cannot be assessed or ruled out.

• 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 33602
• MDR Report Key: 25666978
• Report Number: 3017860045-2026-00010
• Device Sequence Number: 5764635
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: (01)10850828007135(17)260630(30)1(10)LB1598377
• 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: 2025
• Device Explanted Year: 2025
• 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: 06/30/2026
• Device Lot Number: LB1598377
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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 Sex: Male