BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOX

    MDR report key: 7095734 · Received December 7, 2017

    Report

    Report Number
    3006082533-2017-00007
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    April 12, 2015
    Report Date
    November 17, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K141332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CAPTIVA SPINE WAS CONTACTED BY A DISTRIBUTOR REPRESENTATIVE WITH INFORMATION REGARDING A REVISION SURGERY. THE REPRESENTATIVE INDICATED THAT THE PATIENT HAD FALLEN CAUSING A REVISION SURGERY TO REMOVE THE CERVICAL CONSTRUCT. NO DEVICE FAILURES WERE IDENTIFIED. THERE HAVE BEEN NO FURTHER ISSUES REPORTED REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875994 SMARTLOX SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ CAPTIVA SPINE 2431-6545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention