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

Lot Number	LB1553214
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Impaired Healing (2378); Numbness (2415)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The production lot consisted of (b)(4) devices, and according to the device lot history record, all devices released for distribution met the final inspection specifications and sterilization requirements.The identified non-conformances were determined not to have contributed to the occurrence in question.
Event or Problem Description
The patient reported a complete loss of sensation on the left side of their hand three weeks following a prc surgery, which occurred prior to the implantation of the axoguard ha+.Upon further examination, the patient was diagnosed with median nerve entrapment associated with carpal tunnel syndrome.The axoguard ha+ was subsequently implanted during a carpal tunnel surgery approximately 2.5 months ago, with the specific date recorded as (b)(6) 2025.After the carpal tunnel and axoguard ha+ implantation procedure, the surgical wound experienced challenges in healing effectively for a period of about three weeks.Ultimately, the device was explanted during a revision surgery at an unspecified date thereafter.The revision surgery likely involved the removal of part or all of the axoguard ha+ implant.During this procedure, the surgeon utilized a tourniquet on the affected arm and re-closed the wound.Since the revision, the patient has reported ongoing and progressively worsening numbness in the hand, which has resulted in muscle atrophy and significant scarring around the surgical site.The patient has indicated that, despite local wound care support and the use of steri-strips, the wound took nearly a month to close following the revision.Based on information provided by the surgeon, as well as thorough due diligence and lot analysis, it is noted that the patient had undergone various treatments prior to the axoguard ha+ application, and had previously experienced issues.The patient also attempted self-wound care in earlier surgeries, as well as following the revision surgery.Importantly, lot analysis results indicated that the device was manufactured in accordance with specifications, and there have been no other complaints associated with this particular lot.Collectively, this evidence suggests that the observed outcomes are unlikely to be related to the axoguard ha+ nerve protector, and there have been no indications of allergic reactions or foreign body responses to the porcine material used.At this time, the surgeon has expressed uncertainty regarding the management of the patient's condition and has recommended a consultation with a neurologist for further evaluation.

• Brand Name: AXOGUARD HA+ NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; tampa heights 111 w oak ave; tampa 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: 22663082
• Report Number: 3017860045-2025-00006
• Device Sequence Number: 18004498
• Product Code: JXI
• UDI-Device Identifier: 10850828007128
• UDI-Public: 10850828007128
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: 09/05/2025
• Device Lot Number: LB1553214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown