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

Lot Number	LB1608203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device utilization records pulled on 20nov25 shows (b)(4) devices utilized.Recall report pulled on 20nov25 shows (b)(4) devices shipped and invoiced.Complaint lookback was performed on 20nov25 and no other complaints are associated with this lot number.The device history record provided by cook, "a review of the device lot history record indicated the device was manufactured to specifications.The nonconformances would not likely have contributed to the occurrence.The lot produced (b)(4) devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.A review of the customer complaints database revealed one additional complaint associated with the reported lot number.This was (b)(4) complaint (b)(4) and was associated with axogen (b)(4), which related to shipper box damage resulting in damaged device packaging.".
Event or Problem Description
A male patient underwent a cubital tunnel release following a total elbow replacement where axoguard ha+ nerve protector was implanted and the patient experienced persistent pain.On an unknown date, patient underwent a total elbow replacement.Following surgery, patient had pain and no return of motor function.On (b)(6) 2025, patient underwent a cubital tunnel release with axoguard ha+ nerve protector implantation.On (b)(6) 2025 patient went to a new surgeon due to no change in symptoms.When the site was opened, surgeon noted area appeared as a severely tethered plane of scar tissue.The surgeon had to remove the ha+ layers which appeared thick with bands adhering to the nerve.It was noted that there were severe compression points due to scar proximal and distal to where the ha+ had previously been placed.Preoperatively, the ulnar nerve showed a flicker on the emg.Intraoperatively, the emg showed no ulnar function.There were no cultures/pathology performed.No treatment or outcome information available.Surgeon did not report causality.Axogen assessed causality of pain as unlikely.Since the pain was present prior to ha+ implantation, it is unlikely that the device would be the cause.

• Brand Name: AXOGUARD HA+ NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; 111 w oak ave; suite 500; tampa FL 33602
• Manufacturer (Section G): AXOGEN CORPORATION BURLESON; 300 boone rd; ste a3; burleson TX 76028
• Manufacturer Contact: rachel thomas ; 111 w oak ave; suite 500; tampa, FL 33602
• MDR Report Key: 23729388
• Report Number: 3017860045-2025-00016
• Device Sequence Number: 9742909
• Product Code: JXI
• UDI-Device Identifier: 10850828007142
• UDI-Public: 10850828007142
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: 08/13/2026
• Device Lot Number: LB1608203
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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: Male