BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    MDR report key: 5025883 · Received August 24, 2015

    Report

    Report Number
    1835959-2015-00188
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    July 24, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: NERVE CUFF. PRODUCT CODE: JXI. THE 510K NUMBER: K132660. SURGEON INDICATED THAT INFLAMMATION UNDERNEATH AND AROUND THE AXOGUARD NERVE WRAP CAUSED THE NERVE TO BE IRRITATED. THUS LEADING TO FOREIGN BODY LIKE REACTION AND EXPLANTATION. COMMON NAME: NERVE CUFF. PRODUCT CODE: JXI. THE 510K NUMBER: K132660. SURGEON INDICATED THAT INFLAMMATION UNDERNEATH AND AROUND THE AXOGUARD NERVE WRAP CAUSED THE NERVE TO BE IRRITATED. THUS LEADING TO FOREIGN BODY LIKE REACTION AND EXPLANTATION.

    Description of Event or Problem · 1

    PATIENT ORIGINALLY PRESENTED WITH PAIN AND NUMBNESS FOLLOWING INJURY AND BONY FIXATION OF ULNA. (B)(6) PERFORMED SURGERY IN (B)(6) 2015 AND PROTECTED THE ULNAR NERVE (DORSAL SENSORY BRANCH) WITH AN AXOGUARD NERVE PROTECTOR. THERE WAS NEUROLYSIS AND THE AREA WITH PERCEIVED SCARRING WAS WRAPPED WITH THE PROTECTOR. THE PATIENT CAME BACK WITH PERSISTENT PAIN AND (B)(6) PERFORMED EXPLORATORY SURGERY ON (B)(6) 2015. HE FOUND THAT THE AXOGUARD NERVE PROTECTOR LOOKED GOOD, BUT THE NERVE UNDERNEATH WAS NEUROMATOUS AND IRRITATED. THERE WAS NO INFECTION OR SEROMA, BUT THERE WAS SMALL GRANULOMA LIKE FOREIGN BODY REACTION NEAR THE SKIN. THE NERVE WAS EXCISED AND THE SAMPLES WERE SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559238 AXOGUARD NERVE CONNECTOR AND PROTECTOR JXI COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1