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	Hyperresponsive to stimuli (4538)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
20 devices were implanted from this lot with no other complaints.In addition, a review of the device lot history record indicated the device was manufactured to specifications.
Event or Problem Description
The patient had a cubital tunnel release surgery on (b)(6) 2024, during which a device was implanted.This device was later explanted following surgery on (b)(6) 2025.The patient has a long-standing history of diabetes, and the pain at the site of the previous nerve decompression (cubital tunnel release) did not have a specific determined cause.Based on discussions with the surgeon, there are several possibilities for the pain: suboptimal nerve perfusion due to chronic diabetic neuropathy, clinically presenting as chronic neuritis with pain at the inner elbow; significant scarring from the previous surgery that could compress the nerve; tethering of the ulnar nerve during the healing process after the decompression; or a combination of these factors.The application of the product after the ulnar nerve decompression does not indicate that it is the sole cause of the pain, particularly as the patient did not show signs of redness or swelling typically associated with true allergic reactions.Therefore, it is highly unlikely that the observed outcome is connected to the implanted product.

• 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 76028
• Manufacturer Contact: shravani shastry ; tampa heights 111 w oak ave; tampa, FL 33602
• MDR Report Key: 22036844
• Report Number: 3017860045-2025-00001
• Device Sequence Number: 20936311
• Product Code: JXI
• UDI-Device Identifier: 10850828007142
• UDI-Public: 10850828007142
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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
• Device Expiration Date: 12/27/2024
• Device Catalogue Number: AGHA48
• Device Lot Number: LB1513060
• 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: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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: Unknown