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

Lot Number	LB1543229
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no other reported complaints for this lot lb1543229.
Event or Problem Description
A diabetic patient underwent carpal tunnel revision surgery and received an axoguard ha+ nerve protector on (b)(6) 2024.The device was explanted on (b)(6) 2024 due to the patient suffering from some wound complications after patient removed wound dressing as instructed.There is a possibility for allergic reaction, but detection of neutrophils or eosinophils in the culture was not reported following discussion with the pa, which makes it hard to draw any definitive conclusion.Contributing factors may include use of celecoxib which may potentially impact or delay the immune response and macrophage infiltrations necessary for device remodeling as well as patient's diabetes status, which may contribute to delayed wound healing and cellulitis.There is insufficient evidence to conclude that the reported adverse event of wound complications was related to the axoguard ha+nerve protector.

• Brand Name: AXOGUARD HA+NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; tampa heights 111 w oak avenue; tampa
• 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: 20395481
• Report Number: 3017860045-2024-00005
• Device Sequence Number: 17783495
• Product Code: JXI
• UDI-Device Identifier: 00850828007145
• UDI-Public: 00850828007145
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: 08/09/2025
• Device Lot Number: LB1543229
• 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: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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