BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTURA MEDICAL 18MM SCREW

    MDR report key: 14776184 · Received June 21, 2022

    Report

    Report Number
    MW5110419
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ASTURA MEDICAL
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 18M VASD SCREW BROKE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400780 ASTURA MEDICAL 18MM SCREW APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ ASTURA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female