BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1210749 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00590
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 25, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IT WAS REPORTED THAT THE HOSPITAL IS MAINTAINING POSSESSION OF THE IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A LONG HISTORY OF SCOLIOSIS WHICH HAD INCREASED SIGNIFICANTLY OVER THE PAST YEAR WITH A 45 DEGREE CURVE UNDERWENT SURGERY WITH IMPLANT OF POSTERIOR HARDWARE. ONE MONTH PRIOR, THE PATIENT UNDERWENT SURGERY FOR HYDROCEPHALUS. SOMETIME POST-OP, IT WAS REPORTED THAT THE SETSCREWS HAD BACKED OUT OF THE SCREWS AND THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SETSCREW KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention