BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE-LOK MVP SCREW

    MDR report key: 2045610 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00040
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    July 28, 2003
    Report Date
    July 28, 2003
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K013903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE IMPLANT IS COMPRESSED AFTER INSERTION INTO THE BONE. THE DEVICE WAS COMPRESSED (COLLAR ADVANCED) BEFORE INSERTION, WHICH PREVENTS COMPRESSION TOOL TO ADVANCE ANY FURTHER, AND PREVENTS DRIVER FROM MATING WITH SCREW. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVAL: RETURNED DEVICE WAS VISUALLY INSPECTED. THE IMPLANT WAS FULLY COMPRESSED.

    Description of Event or Problem · 1

    IMPLANT PLACED IN POSITION. COMPRESSION DEVICE WOULD NOT ADVANCE COLLAR AS IS CUSTOMARY. REPEATED ATTEMPT TO ADVANCE COLLAR TO NO AVAIL. COMPRESSION PIN REMOVED WITH COMPRESSION PIN REMOVAL TOOL. ATTEMPTED TO REMOVE IMPLANT WITH DRIVER. DRIVER WOULD NOT FIT IN DEVICE. FINALLY, REMOVED DEVICE WITH NEEDLE NOSE PLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE-LOK MVP SCREW MRW INTERVENTIONAL SPINE, INC. SMCD-45-6070S R081502H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention