BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPAN

    MDR report key: 23560626 · Received November 14, 2025

    Report

    Report Number
    3005977257-2025-00004
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    LESSPINE INNOVATIONS
    Product Code
    KWP
    PMA / PMN Number
    K232605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE HAS NOT HAPPENED PREVIOUSLY AND THE IMPLANT WAS FULLY INTACT AND SHOWING NO SIGNS OF DEVICE FAILURE. SUBMISSION WAS AFTER 30 DAY TIMELINE DUE TO WAITING ON MORE CLARIFICATION AND INFORMATION ABOUT THE INCIDENT FROM THE PRACTICING SURGEON. SURGEON CONFIRMED THAT THE PATIENT DID NOT FOLLOW POST OPERATIVE CARE INSTRUCTIONS PROPERLY AND DID NOT USE THE BACK BRACE PROVIDED, RESULTING IN THE FRACTURE.

    Description of Event or Problem · 0

    PATIENT RECEIVED AN INSPAN IMPLANT ON (B)(6) 2025. ABOUT 1 MONTH LATER PATIENT RETURNED COMPLAINING OF PAIN IN THE AREA OF THE IMPLANT. A REMOVAL WAS DONE ON (B)(6) 2025 AND IT WAS DETERMINED THAT THE PATIENT'S SPINOUS PROCESS HAD FRACTURED. THE IMPLANT WAS INTACT AND HAD NO DAMAGE OR FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562318 INSPAN IMPLANT KWP LESSPINE INNOVATIONS 01-61100-1037 IL17C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention