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

Model Number	AGHA48
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a cubital tunnel release surgery on (b)(6) 2024, during which a device was implanted.This device was later explanted following a subsequent surgery on (b)(6) 2025.A general complaint was filed with the axogen representative on (b)(6) 2025, noting that the patient experienced intense pain at the surgical site.Symptoms included pain indicative of compression on the nerve at the surgical site.No other information was shared and medical analysis is pending.
Additional Manufacturer Narrative
6 devices were implanted from this lot with no other complaints.

• Brand Name: AXOGUARD HA+NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; tampa heights 111 w oak ave; tampa 33602
• Manufacturer (Section G): AXOGEN CORPORATION BURLESON; 300 boone rd ste a3; burleson TX 76028
• Manufacturer Contact: shravani shastry ; tampa heights 111 w oak ave; tampa, FL 33602
• MDR Report Key: 21861521
• Report Number: 3017860045-2025-00002
• Device Sequence Number: 4606716
• Product Code: JXI
• UDI-Device Identifier: 10850828007142
• UDI-Public: 10850828007142
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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
• Device Expiration Date: 02/10/2026
• Device Model Number: AGHA48
• Device Lot Number: LB1590869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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: Unknown