BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1070063 · Received July 3, 2008

    Report

    Report Number
    1030489-2008-00312
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    K001255
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECTED DEVICES IN USE ARE LOT # 519733 AND # PTS0929. DEVICE HISTORY RECORDS FOR BOTH LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE AT L4/5 WITH MAST USING POSTERIOR FIXATION FOR SPONDYLOLISTHESIS AND DEGENERATIVE SCOLIOSIS. A ROD ON THE LEFT SIDE WAS PLACED WITH ROD INSERTER ASSEMBLY. DURING THE PROCEDURE, THE ROD COULD NOT GO THROUGH THE HEAD OF THE SCREWS PROPERLY UNDER THE IMAGE. A SURGEON REMOVED THE SCREWS. THE PROCEDURE WAS COMPLETED WITH AN OPEN PROCEDURE. NO OTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD INSERTER LXH MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR