BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUENTIAL DILATOR (DILATOR 1)

    MDR report key: 8012460 · Received October 28, 2018

    Report

    Report Number
    2135156-2018-00008
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Report Date
    October 26, 2018
    Manufacturer
    SPINEOLOGY INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS IMPACTING THE DILATOR INTO THE DISC SPACE AND THE DILATOR TIP BROKE OFF. HE ATTEMPTED TO RETRIEVE IT BUT WAS UNSUCCESSFUL. THE BROKEN TIP WAS POSITIONED AGAINST THE WALL OF THE ANNULUS WHERE THE SURGEON FELT IT AS SECURE. HE LEFT IT IN PLACE AND PROCEEDED WITH AN INTERBODY FUSION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851495 SEQUENTIAL DILATOR (DILATOR 1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINEOLOGY INC S80969

    Patients

    Seq Age Sex Outcome Treatment
    1 163 YR