BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISSYS PEDICLE SCREW

    MDR report key: 1006847 · Received February 25, 2008

    Report

    Report Number
    3005129649-2008-00001
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 25, 2008
    Manufacturer
    CUSTOM SPINE, INC.
    Product Code
    MCV
    PMA / PMN Number
    K045223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A REVISION SURGERY ON A PT WITH A PRIOR PARTIALLY FAILED FUSION IN THE L4-S1 REGION. THE REP STATED THAT THE SURGEON WAS REMOVING ISSYS 7.5 MM DIAMETER SCREWS AND REPLACING THEM WITH A LARGER SCREW 8.5 MM DIA X 40 MM LENGTH (CAT 018540) IN THE REVISED HOLES. THE REP STATED THE SURGEON HAD SUCCESSFULLY INSERTED 5 OF THE 6 SCREWS (L4-S1, RIGHT SIDE AND L4-L5, LEFT SIDE). THE SURGEON ATTEMPTED TO INSERT THE LAST SCREW IN S1 AND HAD A DIFFICULT TIME ADVANCING THE LAST SCREW IN S1. THE REP STATED THE SURGEON USED SEVERAL MANUAL INSTRUMENTS TO DISMANTLE THE POLYAXIAL SCREW HEAD. THE REP STATED THE SURGEON THEN ATTEMPTED TO REMOVE THE FULLY ENTACT SCREW FROM THE BONE WITH NO SUCCESS. THE REP STATED THE DOCTOR USED A POWERED INSTRUMENT TO GRIND DOWN THE SCREW TO THE SURFACE OF THE BONE LEAVING PART OF THE SCREW EMBEDDED IN S1. THE DOCTOR COMPLETED L4-S1 CONSTRUCT ON THE RIGHT SIDE AND L4-L5 ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISSYS PEDICLE SCREW PEDICLE SCREW MCV CUSTOM SPINE, INC. 8.5 MM X 40 MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R