BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1060675 · Received June 13, 2008

    Report

    Report Number
    1030489-2008-00276
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECTED DEVICES IN USE ARE LOT #W06L3963, #W06L3966, #W07A2461, AND #W07A2463. DEVICE HISTORY RECORDS FOR THOSE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE AT L3/5 USING POSTERIOR FIXATION FOR DEGENERATIVE SPONDYLOLISTHESIS. THE PATIENT COMPLAINED OF DISCOMFORT IN LOWER BACK POST OP. IT WAS CONFIRMED THAT THE LEFT SIDE L5 SCREW WAS BROKEN AT UNKNOWN TIME POST OP. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY A YEAR POST OP TO REMOVE THE CONSTRUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention