BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THRESHOLD

    MDR report key: 7095790 · Received December 7, 2017

    Report

    Report Number
    3006082533-2017-00005
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    May 29, 2014
    Report Date
    November 17, 2017
    Manufacturer
    CAPTIVA SPINE
    Product Code
    LXH
    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 PROCEDURE BEING CONVERTED FROM AN MIS APPROACH TO A WILTSE APPROACH. DURING THE PROCEDURE THE ROD CAME OFF THE ROD HOLDER. TO RETRIEVE THE ROD AND COMPLETE THE PROCEDURE THE APPROACH WAS CHANGED FROM A MINIMALLY INVASIVE PROCEDURE TO A WILTSE. ALTHOUGH THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND THERE WAS NO IMPACT TO PATIENT OUTCOME THIS INCIDENT IS BEING REPORTED AS THERE WAS A CHANGE IN THE PLANNED SURGICAL APPROACH DUE TO THE ROD DISENGAGING FROM THE ROD HOLDER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877668 THRESHOLD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CAPTIVA SPINE 530-0080 MC12007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention