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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Synovitis (2094); Fibrosis (3167)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Recall report pulled (b)(6) 2025 shows that (b)(4) devices were invoiced and shipped.The device utilization reports database identified (b)(4) other devices as implanted.Complaint log reviewed did not identify any other complaints associated with the given lot number.Device history record review memo completed by cook stated: a review of the device lot history record indicated the device was manufactured to specifications.The non-conformances would not likely have contributed to the occurrence.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.At this time, there is no indication this is a lot wide issue.
Event or Problem Description
On (b)(6) 2024, patient underwent a carpal tunnel revision with axoguard ha+ nerve protector.This was patient's second surgery at carpal tunnel site.Surgeon noted the median nerve was adherent to transverse carpal ligament, some adherence to flexor tendons, and tenosynovitis.Surgeon dissected scar tissue around the nerve and tenosynovium, trimmed the 3x6 wrap to 3x5, wrapped nerve with ha+ with no sutures, irrigated, and closed skin with 4-0 nylon (single layer closure).On an unknown date over a year after the initial surgery, patient developed a lump at midportion of the surgical site.On (b)(6) 2025, patient went back into surgery for a suspected ganglion cyst with new surgeon.No cyst was found.Surgeon noted nerve looked good, found unusual tissue adhered to the median nerve that looked like possible remnants of the ha+.Also notably, found thickness of tenosynovium.Pathology report showed a combination of benign soft tissue and palisaded histiocytic inflammation with necrobiosis.Tissue was scraped out by surgeon at this time.On (b)(6) 2025 patient had a post-op follow up with nursing staff.Nurse noted patient is recovering well, taking tylenol and ibuprofen for post-op pain, and has good range of motion.No further comments.Surgeon causality was unknown.Pathology findings are most consistent with a foreign body-type reaction at the prior implant site.

• 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: 23880062
• Report Number: 3017860045-2025-00017
• Device Sequence Number: 13163061
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: (01)10850828007135
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/23/2025

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
• 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: 11/23/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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