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

Lot Number	LB1642613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, female patient underwent carpal tunnel revision surgery.At the one-week post-op appointment, patient had redness at the incision site.Surgeon put patient on a few days of doxycycline.At the two-week post-op appointment, patient had worsening redness and pain at the site.Surgeon took patient back to the or, irrigated the site, and noticed the ha+ protector looked like a piece of fatty collagen.The ha+ protector was explanted and fell apart in two pieces.The surgeon had cultures sent which were negative for infection, did not send for pathology.Since the ha+ protector was explanted, events have resolved.No causality was reported, though the surgeon remarked that the patient may have not tolerated the device.Axogen assessed causality as possibly related.Cultures obtained during evaluation were negative, and no pathology was performed, limiting the ability to determine the underlying cause of the reported redness and pain.
Additional Manufacturer Narrative
Recall report pulled 27jan2026 found that 7 products from the same lot had shipped and 3 are labeled as finished goods.The device utilization report pulled 27jan2026 found no products from this lot that have yet been reported implanted.The device history record review memo provided by evergen stated: a review of the device lot history record indicated the device was manufactured to specifications.The nonconformance would not likely contribute to the occurrence.The lot produced 10 devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.

• 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; ste a3; burleson TX 76028
• Manufacturer Contact: rachel thomas ; 111 w oak ave; suite 500; tampa, FL 33602
• MDR Report Key: 24341672
• Report Number: 3017860045-2026-00001
• Device Sequence Number: 18560525
• Product Code: JXI
• UDI-Device Identifier: 10850828007128
• UDI-Public: (01)10850828007128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/15/2026

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: LB1642613
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female