BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2040373 · Received February 15, 2011

    Report

    Report Number
    2032499-2011-00026
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    June 2, 2009
    Report Date
    June 2, 2009
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K062391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE MATING PART DID NOT INSERT INTO TOOL ALL THE WAY. LARGE ID MACHINING CAUSED BURRS IN SMALLER ID. 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

    FIRST PACKAGE: SCREW DRIVER WOULD NOT ALLOW SCREW TO SET INSIDE IT. SECOND PACKAGE: A SECOND PACKAGE WAS OPENED AND THE DRIVER WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MRW INTERVENTIONAL SPINE, INC. 9045-02 050809-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention