BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXOGUARD NERVE CAP

    MDR report key: 20039060 · Received August 22, 2024

    Report

    Report Number
    3017860045-2024-00003
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 22, 2024
    Manufacturer
    AXOGEN CORPORATION
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DUR REPORT FOR AUG 1, 2024 REVEALED THAT SEVEN (7) DEVICES FROM THIS LOT WERE IMPLANTED. THE RECALL REPORT ALSO STATED THAT 15 DEVICES WERE INVOICED AND SHIPPED AS OF AUG 1, 2024. ADDITIONALLY, THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT, SO THERE IS NO NEED TO QUARANTINE LB1541726.

    Description of Event or Problem · 0

    THE SURGEON IMPLANTED THE DEVICE IN (B)(6) 2024 AND PERFORMED A REVISION SURGERY ON (B)(6), 2024 RESULTING IN THE REMOVAL OF THE DEVICE. DURING THE REVISION, IT WAS FOUND THAT THE CAP HAD FAILED TO CONTAIN THE NEUROMA. FURTHER INVESTIGATION REVEALED THAT, DURING THE INITIAL SURGERY, THE NERVE CAP WAS ALTERED BY CUTTING APPROXIMATELY 5MM OFF ITS OPEN SIDE. THE SURGEON MADE THIS MODIFICATION BECAUSE THEY FELT THE CAP WAS TOO LONG FOR ITS INTENDED USE. THE INSTRUCTIONS FOR USE (IFU) DO NOT INDICATE THAT THE DEVICE IS DESIGNED TO BE CUT OR MODIFIED IN THIS MANNER. THIS ALTERATION COULD IMPACT THE DEVICE'S PERFORMANCE, AS THE LUMEN'S SIZE IS SPECIFICALLY ENGINEERED TO SUPPORT ALIGNED NERVE GROWTH UNTIL REGENERATION IS COMPLETE.GIVEN THIS INFORMATION, IT IS UNLIKELY THAT THE OBSERVED ISSUES ARE RELATED TO A DEFECT IN THE DEVICE ITSELF. INSTEAD, THE FAILURE TO CONTAIN THE NEUROMA MAY BE ATTRIBUTED TO THE MODIFICATION OF THE DEVICE BY THE SURGEON. THERE IS NO AVAILABLE DATA ON THE EXTENT OF THE PATIENT'S INJURY OR MOBILITY, AS THE SURGEON HAS NOT RESPONDED TO REQUESTS FOR FURTHER DETAILS. IN CONCLUSION, THE PROBLEMS ENCOUNTERED ARE LIKELY DUE TO THE SURGEON'S TECHNIQUE AND MODIFICATION OF THE DEVICE, RATHER THAN AN INHERENT ISSUE WITH THE PRODUCT. WHILE PAIN IS LISTED IN THE PRODUCT LABELING AS A POSSIBLE OUTCOME, IT IS IMPROBABLE THAT IT IS RELATED TO THE PRODUCT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25997 AXOGUARD NERVE CAP NERVE CUFF JXI AXOGEN CORPORATION LB1541726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention