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

Lot Number	LB1575269
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Neuralgia (4413); Paresthesia (4421)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report pulled 07may2026 identifies 47 devices from the given lot have been invoiced and shipped.Device utilization report log reviewed identifies 28 other devices from this lot as implanted.Complaint log reviewed 07may2026 did not identify any complaints associated with the given lot number.A review of the device lot history record indicated the device was manufactured to specifications.No non-conformances were identified in product released for distribution.The lot produced 50 devices.According to the device lot history record, all devices released for distribution met the final inspection specification requirements and sterilization requirements.As the reported recurrent cubital tunnel symptoms and pain are more consistent with progression or recurrence of the underlying condition in the setting of multiple revision procedures, with no objective evidence suggestive of a device-related complication or infection.
Event or Problem Description
This is an initial, serious, spontaneous report regarding a patient (unknown age/gender) who underwent revision cubital tunnel surgery in which axoguard ha+ nerve protector was implanted and subsequently experienced cubital tunnel syndrome.On (b)(6) 2024, the patient underwent a cubital tunnel revision during which axoguard ha+ nerve protector was implanted.This was patient's second revision.On an unknown date, the patient experienced a return of symptoms including pain, reported to be more proximal than original revision.On (b)(6) 2026, surgeon performed a third cubital tunnel revision, explanting a portion of the previously implanted ha+ and subsequently placing another axoguard ha+ at the site.

• 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 111 ste a3; burleson TX 76028
• Manufacturer Contact: rachel thomas ; 111 w oak ave suite 500; tampa, FL 33602
• MDR Report Key: 25334181
• Report Number: 3017860045-2026-00007
• Device Sequence Number: 18607149
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: (01)10850828007135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 05/29/2026

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: 12/31/2025
• Device Lot Number: LB1575269
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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