BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT POCT

    MDR report key: 1843627 · Received September 20, 2010

    Report

    Report Number
    2183449-2010-00016
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ORTHOFIX INC.
    Product Code
    KWP
    PMA / PMN Number
    K080394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED STATES THAT THE DR HAD DIFFICULTY TRYING TO SET THE ROD DURING A POSTERIOR CERVICAL 4 PROCEDURE. HE COULD NOT GET THE ROD TO FIT AT THE BOTTOM OF THE SADDLE DUE TO THE INTERIOR OF THE SCREW HAVING TURNED 90 DEGREES, WHICH COVERED THE PORTION OF THE TULIP WHICH PREVENTED THE ROD FROM FULLY SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT POCT 3.5MMX18MM MULTI-AXIAL SCREW, ASCENT POC KWP ORTHOFIX INC. 65-3318 P11

    Patients

    Seq Age Sex Outcome Treatment
    1