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

Lot Number	LB1620172
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Recall report pulled 06nov2025 identified 43 devices from this lot as invoiced and shipped.Device utilization records (dur) were pulled 06nov2025 and identified 26 other devices from the lot as implanted.The complaint log was reviewed and did not identify any other complaints associated with lot lb1620172.A review of the device lot history record indicated the device was manufactured to specifications.The nonconformances would not likely contribute to the occurrence.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.
Event or Problem Description
On (b)(6) 2025, patient underwent a carpal tunnel revision with axoguard ha+ (lot unknown to rep; found with internal records as lb1620172) implantation.On (b)(6) 2025, patient underwent third carpal tunnel revision with a possible neuroma excision.Surgeon did not find any nerve damage or neuroma, instead there was only hypersensitivity around the surgical site.During 27-oct surgery, surgeon pulled out a piece of fatty tissue but did not explant the ha+.No cultures/pathology reported.No treatment information, surgical technique, or outcomes reported.Surgeon reported causality as possibly related.Axogen reported causality as unassessable.Based on the limited information and no cutlures/pathology reports, it is impossible to make a firm conclusion.We are unable to determine if other factors, such as surgical technique, comorbidities, or post-operative care contributed to this outcome.

• 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: 23646409
• Report Number: 3017860045-2025-00015
• Device Sequence Number: 4903413
• Product Code: JXI
• UDI-Device Identifier: 10850828007128
• UDI-Public: 10850828007128
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/25/2025

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: 09/24/2026
• Device Lot Number: LB1620172
• 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: 10/27/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: Unknown