BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE

    MDR report key: 1852874 · Received September 29, 2010

    Report

    Report Number
    MW5017627
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    AMENDIA
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE BROKE DURING SURGICAL SPINAL PROCEDURE-RIGHT L5-S1, L4-L5 PERCUTANEOUS OPTIMESH INTERBODY FUSION; UNILATERAL PERCUTANEOUS PEDICLE SCREW PLACEMENT WITH ROD. BROKEN PIECE WAS UNABLE TO BE REMOVED AND REMAINS LODGED IN PT'S SACRUM. BROKEN PIECE MEASURED TO BE 1.5 CM. IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE K-WIRE JDW AMENDIA 9080-18

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other