BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC 4.5MM X 16MM VARIABLE-ANGLE SCREW

    MDR report key: 2822421 · Received June 20, 2012

    Report

    Report Number
    3004893332-2012-00002
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 11, 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

    Description of Event or Problem · 1

    ¿THE RESCUE SCREW IS BACKING OUT OF THE PLATE. ORIGINAL DOS: (B)(6) 2012, REVISION CASE ON (B)(6) 2012, SECOND REVISION (B)(6) 2012 REMOVED RESCUE SCREW LISTED. THIS SCREW (B)(4) WAS THEN REMOVED AND DISCARDED AS THE HOLE WAS TOO BIG.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC 4.5MM X 16MM VARIABLE-ANGLE SCREW SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ SPINAL ELEMENTS, INC. 25045-016 100384

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention