BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2040372 · Received February 15, 2011

    Report

    Report Number
    2032499-2011-00070
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    June 2, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K082795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: INSTRUMENT SUPPLIER LEFT A BURR IN THE DISTAL TIP WHILE MFG. THIS BURR PREVENTED THE INSTRUMENT FROM MATING WITH THE IMPLANT. AS A CORRECTIVE ACTION, THE SUPPLIER REVISED HIS MACHINING PROCESS TO ELIMINATE ANY BURRS AND A FUNCTIONAL FIT TEST WAS IMPLEMENTED AT THE SUPPLIER AND UPON RECEIPT FROM THE SUPPLIER. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVALUATION: RETURNED IMPLANT WAS VISUALLY INSPECTED. DAMAGE WAS SEEN ON TOP OF THE SCREW. INSTRUMENT WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE DRIVER COULD NOT CAPTURE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MRW INTERVENTIONAL SPINE, INC. 9045-02 041409-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention