BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 770182 · Received October 13, 2006

    Report

    Report Number
    3003807094-2006-00004
    Event Type
    Injury
    Date Received
    October 13, 2006
    Report Date
    August 4, 2006
    Manufacturer
    SCIENT ' X USA
    Product Code
    MCV
    PMA / PMN Number
    K990118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RODS CONTRAINDICATED FOR USE WITH OTHER MANUFACTURERS COMPONENTS.

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED TO REMOVE BROKEN SEA SPINE PEDICLE SCREWS USED WITH SCIENT'X ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PEDICLE SCREW SPINAL SYSTEM MCV SCIENT ' X USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other