BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATHFINDER POLYAXIAL SCREW

    MDR report key: 515497 · Received March 10, 2004

    Report

    Report Number
    1649384-2004-00001
    Event Type
    Other
    Date Received
    March 10, 2004
    Date of Event
    October 31, 2003
    Report Date
    February 8, 2004
    Manufacturer
    SPINAL CONCEPTS, INC.
    Product Code
    MCV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    POST OPERATIVE X-RAYS SHOW THAT THE ROD AND CLOSURE TOP WERE NOT CAPTURED WITHIN ONE PEDICLE SCREW. THE PT WAS REVISED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER POLYAXIAL SCREW PEDICLE SCREW MCV SPINAL CONCEPTS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO 1105-6555 POLYAXIAL SCREW, 2101-1 CLOSURE TOP,| 9205-30 PREBENT 5.5MM ROD.