BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 698480 · Received April 7, 2006

    Report

    Report Number
    1030489-2006-00089
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    February 27, 2006
    Report Date
    March 31, 2006
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED APPROXIMATELY 2 WEEKS POST OP DUE TO PAIN. IT IS UNKNOW IF THE DEVICE OR CONTRIBUTED TO THE REPORTED EVENT, BUT WE ARE FILLING THIS MDR OUT OF AND ABUDANCE OF CAUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention