BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2130743 · Received June 16, 2011

    Report

    Report Number
    1030489-2011-00741
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION OF RETURNED SET SCREW ROD INTERFACE SURFACES EXHIBIT SECONDARY WEAR / DAMAGE WHICH INHIBIT DETERMINATION OF ROOT CAUSE WITH RESPECT TO ROD/SET SCREW INTERFACE LOOSENING. WITNESS MARKS NOTED ON MAS CROWN TYPICAL OF FULLY TIGHTENED SET SCREW. DAMAGE NOTED ON EXTERNAL SURFACES OF MULTI-AXIAL SCREWS. THE NATURE AND LOCATION OF THE MAS SURFACE DAMAGE IS CONSISTENT WITH THE CORRESPONDING DAMAGE NOTED ON SET SCREW ROD INTERFACE SURFACES. WITNESS MARKS NOTED ON MAS CROWN TYPICAL OF FULLY TIGHTENED SET SCREW. SET SCREW INTERFACE WITNESS MARKS AT L4 (LOCATION OF SET SCREW DISENGAGEMENT) VISUALLY APPEAR TO BE LESS PRONOUNCED WHEN COMPARED TO THE L5 AND S1 AND THE SAMPLE COCR PLUS ROD SET SCREW ROD INTERFACE WITNESS MARKS. ADDITIONAL ABRASIONS ALSO NOTED CONSISTENT WITH ROD MOVEMENT AFTER SET SCREW LOOSENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. IT WAS REPORTED THAT THE PATIENT HEARD A POP SOMETIME POST-OP. DURING A ROUTINE FOLLOW UP VISIT 6 WEEKS POST-OP IT WAS FOUND THAT THE SET SCREWS HAD BACKED OUT OF THE BONE SCREWS AT L4. THE RODS MOVED POSTERIORLY AND CAUDAL. THE PATIENT UNDERWENT A REVISION SURGERY WITH THE REPLACEMENT OF THE RODS, L4 BONE SCREWS, CROSSLINK AND SET SCREWS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention ROD, SCREWS, CROSSLINK