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

Catalog Number	AGHA48
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a the second revision of the cubital tunnel release, which was the third operation performed on (b)(6) 2024, which involved the implantation of a device.Following this, the device was explanted on (b)(6) 2024 from the median nerve at the elbow (cutr) after infection was reported.It's important to recognize that any surgical intervention carries a risk of infection, as the incision in the skin can provide a pathway for potential infective agents.While the specific cause of the infection could not be determined, it was observed that there was a 30-day period between the surgical intervention and drainage.
Additional Manufacturer Narrative
A review of the device lot history record indicated the device was manufactured to specifications.The non-conformances would not have contributed to the occurrence.The lot produced a total of (b)(4).Per 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; tampa heights 111 w oak ave; tampa FL 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: 22107412
• Report Number: 3017860045-2025-00004
• Device Sequence Number: 15491247
• Product Code: JXI
• UDI-Device Identifier: 10850828007142
• UDI-Public: 10850828007142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/29/2025

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: 10/14/2025
• Device Catalogue Number: AGHA48
• Device Lot Number: LB1562276
• 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: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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