BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOX

    MDR report key: 6532100 · Received April 28, 2017

    Report

    Report Number
    3006082533-2017-00003
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 28, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K141332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 A SMARTLOX CONSTRUCT HAD BEEN REMOVED DURING A REVISION SURGERY. REVISION SURGERY WAS COMPLETED (B)(6) 2017. THE DISTRIBUTOR REPRESENTATIVE PROVIDED IMAGES DATED (B)(6) 2016 AND THE WEEK OF (B)(6) 2017. THE ORIGINAL SURGERY DATED (B)(6) 2016 IMAGE SHOWS ALL SCREWS CONTAINED WITHIN THE LOCKING MECHANISM. THE FOLLOW UP IMAGE DATED (B)(6) 2016 SHOWS TWO SCREWS SITTING SLIGHTLY PROUD. THE FOLLOW UP IMAGE TAKEN THE WEEK OF (B)(6) 2017 SHOWS TWO SCREWS SITTING PROUD. THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2017. THE HARDWARE WAS NOT RETURNED AND THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312123 SMARTLOX SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ CAPTIVA SPINE ST06014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention