BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS SYSTEM: KWIRE

    MDR report key: 2045586 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00019
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    November 19, 2007
    Report Date
    November 19, 2007
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: SUPPLIER MACHINED THE WIRES INCORRECTLY. CRITICAL FEATURES NOT INSPECTED. AS A CORRECTIVE ACTION, ALL WIRES IN INVENTORY WERE REWORKED SO THAT THE WIRES COULD FIT WITHIN THE IMPLANT INNER DIAMETER. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN REMOVED THE K-WIRE, THE IMPLANT CAME WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS SYSTEM: KWIRE MRW INTERVENTIONAL SPINE, INC. 9045-02 050907A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention