BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    MDR report key: 4275618 · Received November 19, 2014

    Report

    Report Number
    1835959-2014-00980
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 19, 2014
    Manufacturer
    COOK BIOTECH
    Product Code
    JXI
    PMA / PMN Number
    K132660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: PRODUCT NOT RETURNED TO CBI. CONCLUSIONS: ROOT CAUSE UNLIKELY RELATED TO DEVICE; INVESTIGATION ONGOING. INVESTIGATION - EVALUATION: INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE FEEDBACK DETAILS, COMMUNICATION WITH AXOGEN FOR FOLLOW-UP WITH SURGEON AND CASE SPECIFIC DETAILS, A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, AND A REVIEW OF THE AXOGUARD NERVE PROTECTOR IFU (B)(4). SUMMARY OF INVESTIGATION FINDINGS: THE ROOT CAUSE OF THE INFECTION IS UNLIKELY RELATED TO THE AXOGUARD NERVE PROTECTOR. INFECTION IS A KNOWN COMPLICATION OF ANY SURGICAL PROCEDURE AND IS LISTED AS A POTENTIAL COMPLICATION IN THE IFU. ADDITIONALLY THE IFU STATES THAT IF AN INFECTION OCCURS AND CANNOT BE RESOLVED, CAREFUL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED. THE INVESTIGATION INTO THIS FEEDBACK IS ONGOING. A FOLLOW-UP MDR WILL BE FILED AS NEW DETAILS ARE RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) OF (B)(6), PERFORMED A CARPAL TUNNEL RELEASE REVISION AND TRIGGER THUMB RELEASE. AN AG0320 WAS IMPLANTED. AT AN UNSPECIFIED TIME POST OP, THE PATIENT DEVELOPED REDNESS AND THERE WAS CONCERN OF INFECTION. THE PATIENT WAS PLACED ON A COURSE OF ORAL ANTIBIOTICS. THE PATIENT HAD ONGOING PAIN AT THE SURGICAL SITE, REDNESS, SWELLING, AND DRAINAGE. ON (B)(6) 2014, DR. (B)(6) COLLEAGUE PERFORMED AN INCISION AND DRAINAGE DUE TO CONCERN OF AN INFECTION. DURING THIS PROCEDURE AXOGUARD WAS NOTED TO HAVE DRAINAGE PRESENT AROUND IT. THE AXOGUARD WAS REMOVED AND SENT TO PATHOLOGY. THE PATHOLOGY REPORT SHOWED THE PRESENCE OF FIBRINOPURULENT EXUDATE AND FOREIGN BODY GIANT CELLS. AS OF (B)(6)2014, THE PATIENT REPORTEDLY HAS ONGOING ISSUES WITH INFECTION AT THE WOUND SITE AND HAS UNDERGONE AN ADDITIONAL INCISION AND DRAINAGE DURING THE WEEK OF (B)(6) 2014. A WOUND CULTURE WAS TAKEN AND SENT OUT FOR EVALUATION. RESULTS OF THIS ARE NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748952 AXOGUARD NERVE CONNECTOR AND PROTECTOR NERVE WRAP JXI COOK BIOTECH LB722042

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R NONE REPORTED BY THE COMPLAINANT