BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS

    MDR report key: 2045588 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00021
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Report Date
    March 20, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE MAIN CAUSE OF THE EVENT WAS THE FACT THAT THE MACHINING OF THE 2080-01 SCREW LEFT A STEP IN THE HOLD BECAUSE OF MIS-MATCHED HOLE CENTERS. ADDITIONALLY, THE K-WIRE OD WAS OVER SPECIFICATION. THUS FURTHER EXACERBATING THE PROBLEM. CORRECTIVE ACTION: AS A CORRECTIVE ACTION, ALL WIRE INVENTORY WAS REWORKED IN ORDER TO ALLOW WIRES TO SLIDE FREELY WITHIN THE IMPLANT'S INNER DIAMETER. ADDITIONALLY, THE DIMENSIONAL REQUIREMENTS FOR THE WIRE'S DISTAL OUTER DIAMETER WERE EXPLICITLY STATED. 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

    K-WIRE WAS STUCK IN THE LUMEN OF A BONE-LOK IMPLANT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS HXI INTERVENTIONAL SPINE, INC. 9045-02 120408-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention