BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2003996 · Received March 1, 2011

    Report

    Report Number
    1030489-2011-00218
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 31, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K040962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PT. PRESENTED FOR SURGERY WITH JUNCTIONAL STENOSIS ABOVE PREVIOUS A L3 TO SACRUM FUSION WITH INSTRUMENTATION. PROCEDURE WAS FOR EXTENSION OF THE PREVIOUS FUSION TO T10, WITH POSTERIOR PEDICLE SCREW INSTRUMENTATION ATTACHED TO THE PREVIOUS INSTRUMENTATION, REMOVAL OF S1 PEDICLE SCREW ON THE RIGHT SIDE, AND DECOMPRESSION WITH PARTIAL FACETECTOMIES BILATERALLY AT L1-L2 AND L2-L3. CROSSLINK, ALLOGRAFT AND DBM MATERIAL WAS PLACED FROM T10 DOWN. ONE MONTH POST-OP THE PT. PRESENTS WITH HAVING A 'CRACKING-BACK SENSATION.' X-RAY SHOWS THE RIGHT SIDED ROD BROKEN AT THE CONNECTOR RIGHT WHERE IT CONNECTS TO THE LOWER PREVIOUS ROD. THE PT. THEN UNDERWENT A PROCEDURE TO REVISE THE BROKEN RIGHT SIDE ROD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE MONTH POST-OP TO REPLACE A BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCREWS