BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1900731 · Received November 16, 2010

    Report

    Report Number
    1030489-2010-01474
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONCOMITANT DEVICE USED IS SCREW. THE IMPLANT DATE IS UNKNOWN. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN BECAUSE OF A BROKEN ROD AND A SCREW. IT SEEMED TO HAVE BEEN A LONG TIME SINCE THE IMPLANT WAS IMPLANTED. NO REVISION SURGERY IS REPORTED AT THIS TIME HOWEVER IT WAS REPORTED THAT THE REVISION SURGERY MAY BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM IMPLANT, FIXATION DEVICE, SPINAL KWQ MEDTRONIC SOFAMOR DANEK USA, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1