BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOX

    MDR report key: 6444981 · Received March 29, 2017

    Report

    Report Number
    3006082533-2017-00002
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    February 2, 2017
    Report Date
    March 29, 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 ((B)(6) 2017) TO INDICATE THAT ONE SMARTLOX SCREW HAD BEEN REMOVED DURING A REVISION SURGERY. PATIENT PRESENTED WITH PAIN DUE TO SCREW PROTRUDING. REVISION SURGERY WAS COMPLETED (B)(6) 2017 AND ONE LOOSE SCREW WAS REMOVED AND BONE PUTTY USED TO FILL IN THE REMAINING HOLE. THE DISTRIBUTOR REPRESENTATIVE INDICATED THAT DURING THE REVISION SURGERY IT WAS CONFIRMED THAT THE REMAINING SMARTLOX SCREWS WERE STILL LOCKED IN THE SMARTLOX PLATE. THE REVISION WAS LIMITED TO ONE SCREW REMOVAL WITHOUT INCIDENT AND WAS DISPOSED OF AFTER REMOVAL. THE REMAINDER OF SCREWS AND PLATE WERE LEFT INTACT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225035 SMARTLOX SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ CAPTIVA SPINE ST06012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S