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

Lot Number	LB-1545726
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994)
Date of Event	05/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The recall report and deviceutilization record (dur) database were reviewed.The recall report indicated that (b)(4) devices were invoiced and sold,and (b)(4) devices in finished goods.A review of the complaint database indicated that there were no other complaints related to this lot #lb1545726.
Event or Problem Description
The patient, a 50-year-old healthy male with no known history of medications and allergies.He underwent cubital tunnel release on (b)(6) 2024, during which the surgeon implanted the axoguard ha+ nerve protector device.According to the surgeon, the patient experienced severe pain, sweating, and nausea after the surgery.The implant was explanted on (b)(6) 2024, and the patient appeared to be doing better.However, no information is available regarding the surgical site's condition or whether wound dehiscence occurred, as the described findings could also be related to an infection at the surgical site.

• Brand Name: AXOGUARD HA+ NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; 111 w oak ave; tampa FL 33602
• Manufacturer (Section G): AXOGEN CORPORATION BURLESON; 300 boone rd ste a3 bu; burleson TX 76028
• Manufacturer Contact: shravani shastry ; tampa heights 111 w oak ave; tampa, FL 33602
• MDR Report Key: 19582190
• Report Number: 3017860045-2024-00002
• Device Sequence Number: 10450079
• Product Code: JXI
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 08/26/2025
• Device Lot Number: LB-1545726
• 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: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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 Age: 50 YR
• Patient Sex: Male