BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS SYSTEM; KWIRE

    MDR report key: 2007071 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00014
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    August 9, 2007
    Report Date
    August 9, 2007
    Manufacturer
    INTERVENTIONAL SPINE., INC.
    Product Code
    MRW
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: UNDER INVESTIGATION. IT SHOULD BE NOTED THAT INITIALLY THIS EVENT WAS DETERMINED TO BE NOT REPORTABLE. UPON RE-REVIEW, IT WAS DECIDED THAT THIS SHOULD BE REPORTED.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF A FACET SCREW, THE K-WIRE LIFTED THE IMPLANT OUT OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS SYSTEM; KWIRE K WIRE MRW INTERVENTIONAL SPINE., INC. 9045-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R