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

Lot Number	LB1628887
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025 the device utilization records (dur) identified 5 other devices from the given lot as being implanted.Additionally, 29 devices from the given lot have been invoiced and shipped.The complaints log was reviewed on (b)(6) 2025 and there were no other complaint associated with the given lot.This complaint is deemed to be an isolated event, and the cause of dehiscence is deemed to be inconclusive.No further action is warranted.A review of the device history record (dhr) indicated the device was manufactured to specifications.The non-conformances are unlikely to have contributed 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
A female patient who underwent axoguard ha+ nerve protector implantation during a carpal tunnel revision surgery, experienced wound dehiscence and device extrusion.On (b)(6) 2025 patient underwent carpal tunnel revision surgery.Surgeon used axoguard ha+ nerve protector (lot lb1628887).On (b)(6) 2025, patient went to follow up appointment where the wound was healing properly except for the bottom portion which was dehisced with a piece of the ha+ sticking out.Surgeon pulled the piece of ha+ out and rep reported it looked like a "weird, long, gooey piece." surgeon went back into the surgical site and noticed the remaining portion of the ha+ was still adhered to the nerve and stated he was surprised how well the ha+ was protecting the nerve.The surgeon left the remaining portion of ha+ in place.Cultures were reported as negative, no copy of report available.Pathology reported fibrous and fibrinous tissue admixed with abundant acute inflammation.No patient compliance, surgical technique, or treatment information provided.Outcome was unknown at time of initial report.Surgeon reported causality to sales representative as unknown.Axogen reported causality as possibly related.Since cultures were negative and pathology results are seemingly indicative of a foreign body reaction, it is possible that the events could be attributed to the axoguard ha+.The patient's past medical history could also be a contributing factor as diabetes can impair would healing.

• 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 ; 5617890884
• MDR Report Key: 23634880
• Report Number: 3017860045-2025-00014
• Device Sequence Number: 13106847
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: 10850828007135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/21/2025

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 Lot Number: LB1628887
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: Hospitalization
• Patient Sex: Female