BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOX

    MDR report key: 6230958 · Received January 6, 2017

    Report

    Report Number
    3006082533-2017-00001
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 6, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K141332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CAPTIVA SPINE DISTRIBUTOR REPRESENTATIVE CONTACTED CAPTIVA TO INDICATE THAT SMARTLOX PLATE AND SCREWS HAD BEEN REMOVED DURING A REVISION SURGERY. PATIENT WAS PRESENTED ON (B)(6) 2016 WITH DISCOMFORT AND X-RAY SHOWED CEPHALAD PORTION OF THE PLATE WAS BACKING OFF THE VERTEBRAE. REVISION SURGERY WAS COMPLETED AND ALL HARDWARE REMOVED ON (B)(6) 2016. THE DISTRIBUTOR REPRESENTATIVE INDICATED THAT DURING THE REVISION SURGERY IT WAS CONFIRMED THAT ALL THE SMARTLOX SCREWS WERE STILL LOCKED IN THE SMARTLOX PLATE. IT WAS CONFIRMED THAT THE CONSTRUCT WAS COMING OFF THE BONE. PATIENT IS A SMOKER AND HAS POOR BONE QUALITY. THE DISTRIBUTOR REPRESENTATIVE ALSO NOTED THAT THERE WERE MANY OSTEOPHYTES ON THE PATIENT'S ANTERIOR CERVICAL SPINE DURING THE REVISION SURGERY. THE IMPLANTS WERE REMOVED WITHOUT INCIDENT AND IMPLANTS WERE DISPOSED OF AFTER REMOVAL. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12996 SMARTLOX SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ CAPTIVA SPINE CP30022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention