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

Lot Number	LB1578799
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent carpal tunnel revision surgery using the axoguard ha+ nerve protector.Three weeks post-surgery, on (b)(6) 2025, the patient consulted the surgeon, reporting symptoms of pain, redness, and swelling.The surgeon noted that these symptoms began approximately three weeks following the procedure.Unfortunately, there is a lack of information regarding the treatment provided, patient compliance, or the surgical technique used.On the same day, the surgeon proceeded to explant the device.Samples were sent for culture and pathology analysis, which returned negative culture results.However, the pathology report indicated the presence of a giant cell reaction as well as lymphocytic infiltrate.The outcome of these events is currently undetermined.In the initial report, the surgeon did not provide a causality assessment concerning the reported events.Axogen has classified the causality as possibly related, based on the pathology findings suggesting a potential foreign body reaction.Nonetheless, considering the lot analysis data that shows no other complaints or adverse events associated with this lot, it is conceivable that this adverse event might be an isolated incident, highlighting the need for further information to reach a definitive conclusion.An email inquiry was sent to the surgeon for additional information, but no response has been received to date.Consequently, no further follow-up is anticipated at this time.
Additional Manufacturer Narrative
On august 11, 2025, axogen reported that (b)(4) devices from the lot were used, and (b)(4) were invoiced and sold.The complaint log showed no additional complaints.The device history record (dhr) confirmed that the devices met specifications.

• 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: 22976999
• Report Number: 3017860045-2025-00008
• Device Sequence Number: 18377116
• Product Code: JXI
• UDI-Device Identifier: 10850828007135
• UDI-Public: 10850828007135
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2026
• Device Lot Number: LB1578799
• 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: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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