BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1060271 · Received June 10, 2008

    Report

    Report Number
    1030489-2008-00269
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 12, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR ALIF AT L4-S1 WITH POSTERIOR DYNAMIC ROD FIXATION AT L3-S1. X-RAYS TAKEN IN 2008 REVEALED TWO BROKEN CANNULATED PEDICLE SCREWS AT L3. THE PT UNDERWENT ADD'L SURGERY TO REMOVE ALL POSTERIOR IMPLANTS. SOLID FUSION HAD OCCURRED AND NO ADD'L HARDWARE WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention