BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT LUMBOSACRAL IMPLANTS

    MDR report key: 2173535 · Received July 23, 2011

    Report

    Report Number
    2242816-2011-00082
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    EBI, LLC
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE EXAMINATION, THE SURGEON IDENTIFIED A BROKEN SCREW FROM AN XRAY IMAGE. SCREW REMAINS IMPLANTED.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT LUMBOSACRAL IMPLANTS SCREW MNH EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1