BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E³ MIS PEDICLE SCREW SYSTEM

    MDR report key: 7901605 · Received September 24, 2018

    Report

    Report Number
    7901605
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 10, 2018
    Manufacturer
    DEGEN MEDICAL, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LOADING ROD FOR INSERTION AND ROD INSERTER PIECE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742288 E³ MIS PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB DEGEN MEDICAL, INC. 06-03N

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA