BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THRESHOLD

    MDR report key: 7095735 · Received December 7, 2017

    Report

    Report Number
    3006082533-2017-00006
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    December 17, 2014
    Report Date
    November 17, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MNI
    PMA / PMN Number
    K131538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 BROKEN SCREW. THE ORIGINAL IMPLANTATION WAS COMPLETED ON (B)(6) 2013. THE PATIENT REPORTED A SLIP AND FALL OCCURRED ON (B)(6) 2014. REVISION SURGERY WAS COMPLETED ON (B)(6) 2015 TO REPLACE A BROKEN LOWER SCREW. THE REVISION SURGERY WAS UNEVENTFUL. CAPTIVA HAS DETERMINED THAT THE SLIP AND FALL (TRAUMA) CONTRIBUTED TO THE HARDWARE BREAKAGE. THERE HAVE BEEN NO FURTHER ISSUES REPORTED REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875995 THRESHOLD THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM MNI CAPTIVA SPINE 2431-6545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention