BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATOMIC 4.0MM X 16MM VARIABLE-ANGLE SCREW

    MDR report key: 2858194 · Received June 20, 2012

    Report

    Report Number
    3004893332-2012-00004
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 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

    INVESTIGATION DESCRIPTION. (B)(6) ON (B)(4) 2012. THE RETURNED SCREW WAS EXAMINED MICROSCOPICALLY. A NOTICEABLE HELICAL GROOVE WAS SEEN ON THE HEAD OF THE SCREW. IT IS UNCLEAR IF THIS GROOVE WAS CREATED UPON INSERTION OR WHEN THE SCREW BACKED OUT OF THE PLATE. THERE IS EVIDENCE THAT THE LOCKING MECHANISM WAS DEPLOYED. SPECIFICALLY, THERE IS DEFORMATION WITHIN THE LOCKING SCREW DRIVE FEATURE AND THE CLIP IS PERMANENTLY EXPANDED. THE SCREW WAS PLACED INTO AN ATOMIC PLATE AND DID LOCK UPON ACTUATION OF THE LOCKING MECHANISM. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    "SCREW IS BACKING OUT. ORIGINAL DOS: (B)(6) 2012. REVISION CASE ON (B)(6) 2012. REMOVED SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC 4.0MM X 16MM VARIABLE-ANGLE SCREW SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS, PRODUCT CODE: KWQ KWQ SPINAL ELEMENTS, INC. 25040-016 080118

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R