BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIUS M-INI IMPLANTS

    MDR report key: 2163029 · Received July 15, 2011

    Report

    Report Number
    2242816-2011-00080
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE FINAL TIGHTENING OF THE MIDDLE SCREW OF A CROSS CONNECTOR, THE SCREW STRIPPED AND POPPED OUT. AS THE OTHER TWO SCREWS WERE ALREADY IN PLACE TORQUED DOWN, THE SURGEON WAS UNABLE TO REMOVE THE CONNECTOR. THE BROKEN SCREW WAS DISCARDED AND CONNECTOR REMAINS IN PATIENT. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTIUS M-INI IMPLANTS 25MM-38MM CROSS CONNECTOR MEDIUM KWP EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1