BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THEKEN

    MDR report key: 7464313 · Received April 25, 2018

    Report

    Report Number
    MW5076767
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 13, 2018
    Report Date
    April 24, 2018
    Manufacturer
    THEKEN COMPANIES, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A 1 INCH PIECE OF A METAL PEDICLE PROBE BROKE OFF IN THE BONE OF RIGHT L5 VERTEBRAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300313 THEKEN PEDICLE FINDER, MANUAL SURGICAL INSTRUMENT LXH THEKEN COMPANIES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR