BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOGUARD HA+ NERVE PROTECTOR

    MDR report key: 20277784 · Received September 23, 2024

    Report

    Report Number
    3017860045-2024-00004
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 23, 2024
    Manufacturer
    AXOGEN CORPORATION
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE NONCONFORMANCE'S WOULD NOT HAVE CONTRIBUTED TO THE OCCURRENCE. THE LOT PRODUCED A TOTAL OF (B)(4). ACCORDING TO THE DEVICE LOT HISTORY RECORD, ALL DEVICES RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION AND STERILIZATION REQUIREMENTS.

    Description of Event or Problem · 0

    THE SURGEON IMPLANTED THE DEVICE ON (B)(6) 2023, FOR A CARPAL TUNNEL REVISION AND EXPLANTED THE DEVICE ON (B)(6) 2024. BASED ON THE INFORMATION PROVIDED BY THE SURGEON, THE PATIENT REMOVED THE WOUND DRESSING HERSELF, WHICH RESULTED IN A SKIN INFECTION AND THE AXOGUARD HA+NERVE PROTECTOR WAS PROPHYLACTICALLY REMOVED TO ELIMINATE ANY POTENTIAL RISKS FROM A FOREIGN BODY IN AN INFECTED FIELD. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE OBSERVED OUTCOME IS RELATED TO THE PRODUCT. THERE IS INSUFFICIENT EVIDENCE TO CONCLUDE THAT THE REPORTED ADVERSE EVENT OF SKIN INFECTION WAS RELATED TO THE AXOGUARD HA+ NERVE PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502254 AXOGUARD HA+ NERVE PROTECTOR NERVE CUFF JXI AXOGEN CORPORATION LB1556680

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention