BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ELEMENTS IMP LMBR PK

    MDR report key: 6456469 · Received March 31, 2017

    Report

    Report Number
    MW5068882
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 31, 2017
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROVIDER WAS PUTTING IN LUMBAR SPINAL CAGE AND CAGE BROKE. PROVIDER RETRIEVED THE BROKEN PIECE AND THE REST OF THE CAGE WAS LEFT IN PLACE. IMAGING REVEALED THAT THE REMAINING CAGE WAS IN PROPER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233898 SPINAL ELEMENTS IMP LMBR PK SPINAL ELEMENTS IMP LMBR PK KWQ SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR