BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ELEMENTS SCREWDRIVER

    MDR report key: 7475319 · Received April 30, 2018

    Report

    Report Number
    MW5076927
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 11, 2018
    Report Date
    April 27, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FINAL TIP OF DRIVER BROKE DURING USE. THE TIP CAME OFF, AND IT IS UNKNOWN IF THE SCREW WAS IN PLACE OR NOT. AN X-RAY WAS DONE AFTER THE PROCEDURE AND NO MISPLACED METAL WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314495 SPINAL ELEMENTS SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL LXH SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR