BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW DRIVER

    MDR report key: 2480366 · Received February 28, 2012

    Report

    Report Number
    3008657535-2012-00019
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE SCREW DRIVER BROKE WHILE THE SURGEON WAS INSERTING THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW DRIVER BF-THORACIC MNI THEKEN SPINE LLC W9308

    Patients

    Seq Age Sex Outcome Treatment
    1