BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPLOX II

    MDR report key: 6048521 · Received October 21, 2016

    Report

    Report Number
    3006082533-2016-00005
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    August 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MNH
    PMA / PMN Number
    K131538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ONSITE VISIT DISTRIBUTOR REPRESENTATIVE RETURNED BROKEN IMPLANTS TO CAPTIVA SPINE REPRESENTATIVE. CAPTIVA FOLLOWED UP WITH THE REPRESENTATIVE TO OBTAIN DETAILS REGARDING THE INCIDENT. THE REPRESENTATIVE INDICATED THAT THE IMPLANTS WERE REMOVED DURING A REVISION PROCEDURE. THE REVISION SURGERY HAD BEEN SCHEDULED DUE TO PATIENT HAVING BEEN IDENTIFIED WITH A CYST AND THE SURGICAL PLAN WAS TO REMOVE THE CYST, REPLACE THE HARDWARE AND EXTEND THE CONSTRUCT. DURING THE PROCEDURE WHEN THE SURGEON WAS REMOVING TWO OF THE SCREWS, THEY HAD TO BE REMOVED IN TWO PIECES. ACCORDING TO THE REPRESENTATIVE DURING THE PRE-OPERATIVE EVALUATION THERE WAS NO INDICATION THAT THE SCREWS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697648 CAPLOX II PEDICLE SCREW SPINAL SYSTEM MNH CAPTIVA SPINE 2412-6540 06140004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention