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

Lot Number	LB1634940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Purulent Discharge (1812)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is an initial, serious, spontaneous report received from a sales representative via surgeon regarding a patient who underwent tarsal tunnel decompression in which axoguard ha+ nerve protector was implanted and experienced purulent discharge.On (b)(6) 2025, the patient underwent a tarsal tunnel decompression where axoguard ha+ nerve protector was implanted.The surgeon laid the ha+ flat over the nerve and did not suture it in place.In (b)(6) 2026, the surgeon was made aware of concerns for a possible infection with purulent discharge at the surgical site.During explantation, the wrap fell apart into two pieces and the surgeon noted that it almost looked like ha+ was extruding, as the material was located close to the incision site upon opening.The surgeon cleaned the site and performed closure in the clinic.
Additional Manufacturer Narrative
Device utilization record for lot lb1634940 was pulled on 05mar2026.13 devices from this lot have reportedly been implanted without issue.The recall report for the lot was pulled on 06mar2026.41 devices from this lot have been invoiced and shipped.A review of the device lot history record indicated the device was manufactured to specifications.No non-conformances were identified in products released for distribution.The lot produced (b)(4) devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.No other complaints have been reported.

• 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): AXOGEN CORPORATION BURLESON; 300 boone rd 111 ste a3; burleson TX 76028
• Manufacturer Contact: rachel thomas ; 111 w oak ave suite 500; tampa, FL 33602
• MDR Report Key: 24780735
• Report Number: 3017860045-2026-00003
• Device Sequence Number: 6065281
• Product Code: JXI
• UDI-Device Identifier: 10850828007128
• UDI-Public: (01)10850828007128
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/03/2026

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 Lot Number: LB1634940
• 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: 03/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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: 48 YR
• Patient Sex: Male