BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLOX

    MDR report key: 7095738 · Received December 7, 2017

    Report

    Report Number
    3006082533-2017-00009
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    August 25, 2015
    Report Date
    November 17, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    KWQ
    UDI-DI
    M739CP300670
    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 RECEIVED A RETURNED CERVICAL PLATE ON (B)(6) 2015 FROM A DISTRIBUTOR. THE DISTRIBUTOR REPRESENTATIVE WAS CONTACTED FOR FURTHER INFORMATION REGARDING THE RETURNED DEVICE. THE REPRESENTATIVE INDICATED THAT REVISION SURGERY WAS COMPLETED AFTER IT WAS IDENTIFIED THAT THE HARDWARE WAS PULLING OUT OF THE BONE IN AN X-RAY. CAPTIVA SPINE COMPLETED AN INVESTIGATION AND DETERMINED THAT THERE WERE NO SIGNS OF UNUSUAL WEAR OR DETERIORATION OF THE HARDWARE. IT IS UNCLEAR AS TO WHY THE CONSTRUCT WAS PULLING OUT OF THE BONE. THERE HAVE BEEN NO ADDITIONAL REPORTS REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876279 SMARTLOX SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ CAPTIVA SPINE CP30067 01120218 M739CP300670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention