BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC 4.0MM X 14MM FIXED ANGLE SCREW

    MDR report key: 2822390 · Received June 25, 2012

    Report

    Report Number
    3004893332-2012-00003
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    March 26, 2012
    Report Date
    May 30, 2012
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON PT FOLLOW-UP ON (B)(6), SURGEON NOTICED THAT SCREW IS BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC 4.0MM X 14MM FIXED ANGLE SCREW SPINAL INTERVERTEBRAL BODY FIXATION ORTHROSIS KWQ SPINAL ELEMENTS, INC. 25140-014 070381, 070883

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R