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

Model Number	AGHA36
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Wound Infection (2447)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon successfully implanted the device on (b)(6) 2024, along the superficial peroneal nerve in the patient's foot.However, during a subsequent post-operative follow-up, the patient developed an infection at the wound site.The surgeon noted purulence and observed a small object protruding from the wound, which led to the complete removal of the device on (b)(6) 2024.At the time of implantation, there were no signs of infection, indicating that the procedure went well initially.It appears that the anatomical placement of the device on the dorsum of the foot, along with the limited protective tissue in that area, may have contributed to the subsequent wound dehiscence and infection.Nevertheless, there is currently insufficient evidence to establish a direct link between these complications and the axoguard ha+nerve protector.
Additional Manufacturer Narrative
On october 29, 2024, a review indicated that 14 devices from the specified lot were successfully invoiced and shipped, while 19 devices remain available in finished goods.Additionally, a dur report revealed that 4 other devices from this lot have been implanted.A thorough complaints lookback was conducted on october 24 and 29, 2024, with no complaints identified related to lot lb1574293.In total, (b)(4) devices were produced from this lot, and all released devices met the final inspection and sterilization requirements, demonstrating our commitment to quality and safety.

• 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: 20743232
• Report Number: 3017860045-2024-00008
• Device Sequence Number: 14753504
• Product Code: JXI
• UDI-Device Identifier: 00850828007138
• UDI-Public: 850828007138
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 10/23/2025
• Device Model Number: AGHA36
• Device Lot Number: LB1574293
• 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: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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