BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

    MDR report key: 8432725 · Received March 18, 2019

    Report

    Report Number
    MW5084999
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 27, 2019
    Report Date
    March 15, 2019
    Manufacturer
    INNOVASIS INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING REMOVAL OF LUMBAR HARDWARE WHEN THE TIP OF A SCREWDRIVER BROKE OFF INTO THE PT. FOREIGN BODY WAS RECOVERED AND NO HARM WAS CAUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224176 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB INNOVASIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR