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

Lot Number	LB1609416
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Ha+ was implanted on (b)(6) 2025 to manage the patient's discomfort from a previous palmaris longus harvest related to a trapeziectomy for a suspension plasty, the surgeon performed an incision just above the wrist.In this procedure, ha+ was applied as an adhesion barrier to protect the tendons in the wrist, where the patient had been experiencing inflammation.Although the use of ha+ on the tendon was communicated as off-label, the surgeon made a decision to utilize it, drawing on his clinical expertise and judgment for the patient's benefit.However, post-operative complications arose, leading to an infection that necessitated the removal of the ha+ device.

• 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: 22749098
• Report Number: 3017860045-2025-00007
• Device Sequence Number: 21219187
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: 10850828007135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/08/2025

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: 08/25/2026
• Device Lot Number: LB1609416
• 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: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown