BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA

    MDR report key: 1081420 · Received July 24, 2008

    Report

    Report Number
    MW5007793
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 24, 2008
    Manufacturer
    K2M
    Product Code
    MCV
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 6.5 MM MESA PEDICLE SCREW BROKE AT SPINAL LEVEL SACRAL-1 LEFT PEDICLE. THE PT WAS INSTRUMENTED FROM LUMBAR 4-SACRAL 1. THE OTHER 5 SCREWS WERE 7.5 MM IN DIAMETER AND DID NOT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESA PEDICLE SCREW MCV K2M 801-06545

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization