BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM FENESTRATED SCREW OPEN CANNULA

    MDR report key: 8527661 · Received April 17, 2019

    Report

    Report Number
    MW5085969
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 15, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL / DEPUY, INC.
    Product Code
    MNI
    UDI-DI
    10705034199528
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE CEMENT WAS BEING INSERTED INTO THE SCREW, THE TIP OF THE INSERTION DEVICE BROKE OFF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316509 EXPEDIUM FENESTRATED SCREW OPEN CANNULA ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDOS INTERNATIONAL SARL / DEPUY, INC. 279726500 LC31508 10705034199528

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR