BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL PEDICLE SCREW 6.5 X 45

    MDR report key: 1033982 · Received April 24, 2008

    Report

    Report Number
    1649384-2008-00220
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN. EVALUATION IS PENDING UPON THE RETURN OF THE PROUDCT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL PEDICLE SCREW 6.5 X 45 PATHFINDER MCV ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention