BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2113247 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00674
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RADIOGRAPHIC IMAGES SHOW A COMPLEX SCOLIOSIS CONSTRUCT INITIALLY T12 TO ILIAC CREAST. RIGHT SIDED ROD WITH ACUTE ANGULATION AT L3 WENT ON TO FRACTURE AND REVISION WAS DONE. ILIAC SCREWS REMOVED AND CAPSTONE PEEK INSERTED AT L5. REINSTRUMENTATION COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WITH ROD AND SCREW IMPLANTATION. SOMETIME POST-OP, IT WAS DISCOVERED THAT A ROD WAS BROKEN. THE REPORTER ADDITIONALLY STATED "MOBILIZATION OF MEANS OF SYNTHESIS." THE PATIENT REQUIRED SURGERY AND HOSPITALIZATION. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR