BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1870988 · Received October 8, 2010

    Report

    Report Number
    1030489-2010-01315
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. FURTHER DETAILS ABOUT THE DEVICES ASSOCIATED WITH THIS EVENT. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1 WITH RODS, SCREWS AND VERTEBRAL BODY REPLACEMENTS. THE PT REPORTED HEARING A SQUEAKING SOUND A COUPLE OF MONTHS POST-OP. IT WAS DECIDED 7 MONTHS POST-OP TO PERFORM A REVISION SURGERY TO REVISE THE HARDWARE TO ELIMINATE ANY LOOSE PARTS THAT MAY BE CAUSING THE SQUEAKING. DURING THE REVISION, THE SET SCREWS, RODS, AND THE BONE SCREW AT L4 WERE REPLACED. THAT EVENING, THE SURGEON WAS INFORMED THAT THE ISSUE WAS NOT RESOLVED AND A SECOND REVISION SURGERY WAS SCHEDULED TO BE PERFORMED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM UNK NKB MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| RODS| IMPLANTED:| SET SCREWS| IMPLANTED:| BONE SCREW| EXPLANTED:| EXPLANTED:| IMPLANTED: