BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREWS

    MDR report key: 8555744 · Received April 25, 2019

    Report

    Report Number
    MW5086212
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SET SCREW PLACED OVER ILIAC BOLT WITH PT'S LAST SURGERY IN MARCH. THE SET SCREWS ON THE RIGHT AND LEFT, BOTH WERE NOTED TO BE DISLODGED FROM THE ILIAC BOLTS AND WERE VISIBLE VIA X-RAY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343485 SET SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ASTURA MEDICAL ABAA00055

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention