BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3844068 · Received June 2, 2014

    Report

    Report Number
    1030489-2014-02695
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    November 8, 2011
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LITERATURE ARTICLE ENTITLED "FENESTRATED PEDICLE SCREWS FOR CEMENT-AUGMENTED PURCHASE IN PATIENTS WITH BONE SOFTENING: A REVIEW OF 21 CASES" THAT A "PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE TO TEAT POST-TRAUMATIC KYPHOSIS. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT FELL OFF OF A LADDER AND SUFFERED FRACTURES IN THE PROXIMAL AND DISTAL ANCHORAGE VERTEBRAE ALLOWING THE IMPLANTS TO MOBILIZE. DUE TO THE POOR CONDITION OF THE PATIENT THE SYSTEM WAS REMOVED AND A VERTEBROPLASTY WAS PERFORMED ON THE INJURED VERTEBRAE." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322078 CD HORIZON SPINAL SYSTEM NEK MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1