BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNANAIL MINI

    MDR report key: 25048925 · Received April 30, 2026

    Report

    Report Number
    3007593722-2026-00003
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE CASE DOING AN OG MINI NAIL FOR SUBTABAR FUSION, THE TRANDVERSETLAR SCREW WENT IN COMPLETELY FINEM THE CALCANEAL DRILL WENT IN COMPLETELY FINE, BUT THE CALCANEAL SCREW WOULDN'T ADVANCE THROUGH THE NAIL. TWO SCREWS AND NEITHER WOULD GO THROUGH. THIS CAUSED A 1.5-HOUR DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190120 DYNANAIL MINI UNKNOWN PART FOR ACTIVE ADAPTIVE LXH MEDSHAPE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1