BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILO

    MDR report key: 3032104 · Received March 28, 2013

    Report

    Report Number
    3032104
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127573 SILO ORTHOSIS, SPINAL HWC MEDTRONIC SOFAMOR DANEK USA, INC * H11F2476

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR