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

Catalog Number	AGHA36
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a cubital tunnel revision surgery took place on (b)(6) 2024, which involved the implantation of a device.Following this, the device was explanted on (b)(6) 2025.The pathology report from the explant surgery ruled out infection, noting only a few polymorphonuclear leukocytes and no identifiable organisms.This, along with the independent assessments by both the primary surgeon and a consultant from axogen, suggests that there may have been a foreign body inflammatory reaction related to the implanted device.It's crucial to consider the timeline surrounding the patient's condition.Just five days post-surgery, the patient was involved in a car accident, which necessitated an operating room admission and a change in the initial surgical dressing.The dressing was reportedly applied tighter than usual, but both the surgeon and the principal investigator (pi) did not find a direct correlation between the accident and the post-surgical complications observed.Regarding the possibility of the observed events being a response to the porcine material of the device, it cannot be outright dismissed.However, the mri findings suggested that the nerve appeared normal with no signs of edema or hyperthermia, differentiating it from a true allergic reaction.The discovery of murky fluid in the surrounding tissue raises concerns, potentially indicative of an inflammatory response, but it does not conclusively establish an allergic response.In summary, while there remains a possibility that the porcine material could provoke a reaction, the evidence currently points away from a direct relationship due to the normal mri findings associated with the nerve and the specific characteristics of the inflammatory response observed.Further investigation and clinical correlation are necessary to determine the exact cause of the observed events and their relationship to the surgical intervention.
Additional Manufacturer Narrative
The dur log indicated that 34 other devices were implanted and 45 devices have been invoiced.In addition, the dhr review indicates that 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: 21992577
• Report Number: 3017860045-2025-00003
• Device Sequence Number: 20910961
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: 10850828007135
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/09/2025

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: 09/04/2025
• Device Catalogue Number: AGHA36
• Device Lot Number: LB1549849
• 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: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PRODUCT DISCARDED
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown