BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2173439 · Received July 23, 2011

    Report

    Report Number
    1030489-2011-00916
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T10-PELVIS WITH PEDICLE SUBTRACTION OSTEOTOMY AT L2. IT WAS REPORTED THAT 8-10 WEEKS POST-OP THE SETSCREWS CAME OUT OF THE PEDICLE SCREWS AT THE TOP OF THE CONSTRUCT. AS A RESULT THERE WAS A LOSS IN CORRECTION ABOVE THE PSO SITE. A REVISION SURGERY HAS NOT BEEN SCHEDULED AS OF YET. THE PATIENT EXPERIENCED BACK PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other BONE SCREWS, RODS