BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2307216 · Received September 28, 2011

    Report

    Report Number
    2307216
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 28, 2011
    Manufacturer
    SPINAL USA LLC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * 5.5 MM LUMBAR PEDICLE SCREW TAP KWP SPINAL USA LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR