BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS BONESCALPEL

    MDR report key: 22154626 · Received June 5, 2025

    Report

    Report Number
    2435119-2025-00031
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    PMA / PMN Number
    K231117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BONESCALPEL ACCESS (BSA) HANDPIECE USED DURING THE ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE HAS NOT YET BEEN RECEIVED FOR EVALUATION AND THE SPECIFIC INVESTIGATORY ACTIONS TO DETERMINE THE POTENTIAL CAUSE OF THE REPORTED EVENT HAVE NOT YET BEEN FULLY DETERMINED. THE INVESTIGATION OF THE REPORTED ISSUE IS ON-GOING, AND CONCLUSIONS OF THE INVESTIGATION ARE NOT YET AVAILABLE.

    Description of Event or Problem · 0

    ON MAY 06, 2025, MISONIX® LLC., A BIOVENTUS® CO., RECEIVED A REPORT OF THE BLACK SHEATH ON A NEXUS® BONESCALPEL® ACCESS (BSA) HANDPIECE REACHING AN OPERATING TEMPERATURE THAT RESULTED IN A BURN TO THE PATIENT'S SKIN (AT THE SURGICAL INCISION) DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE. FOLLOWING THE SURGERY A BURN OINTMENT WAS APPLIED TO THE AFFECTED SKIN. NO FURTHER INTERVENTION WAS TAKEN DURING OR FOLLOWING SURGERY FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307574 NEXUS BONESCALPEL BONESCALPEL ACCESS (BSA) HANDPIECE LFL MISONIX, INC. 100-22-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other