BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1020019 · Received March 27, 2008

    Report

    Report Number
    1030489-2008-00157
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 20, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS RETURNED TO MEDTRONIC FOR EVALUATION. EVALUATION IS CURRENTLY IS PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY IN 2008 TO REMOVE A BROKEN ROD AT L2-3. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD NQP WARSAW ORTHOPEDIC INC NA AT2006110250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention