BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4124046 · Received September 27, 2014

    Report

    Report Number
    1030489-2014-03747
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 1, 2013
    Report Date
    August 29, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K040962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REDO L2-S1 FUSION PLUS T9-S1 FUSION INSTRUMENTATION WITH PLACEMENT OF TRANSPEDICULAR SCREWS AT T9, T10, T11, T12. L1 PEDICLE SCREWS WERE REMOVED; REVISION OF INTERBODY FUSION L1-L2, WITH REVISION OF THE L1-L2 CAGE; L1 KYPHOPLASTY. AUTOLOGOUS BONE AND DBM WERE USED FOR BONE GRAFTING. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE SITE OF THE SURGICAL WOUND. APPROXIMATELY 1 MONTH POST-OP, THE PATIENT UNDERWENT A PROCEDURE FOR DEBRIDEMENT OF THE WOUND. IT IS NOTED THAT PATHOLOGY REPORTS INDICATE E.COLI WAS PRESENT IN DEEP TISSUE AT THE SURGICAL SITE. APPROXIMATELY 3 YEARS POST-OP, PRIOR TO GALL BLADDER SURGERY, PRE-SURGICAL X-RAY SUGGESTED THAT ONE OF THE RODS FROM THE INDEX SURGERY HAD FRACTURED. REPORTEDLY THE PATIENT¿S PAIN AND KYPHOSIS BECAME MORE SEVERE. AT 42 MONTHS POST-OP, THE ROD WAS CONFIRMED TO BE FRACTURED. AT 45 MONTHS POST-OP, THE PATIENT UNDERWENT ADDITIONAL SURGERY. PRE-OPERATIVE DIAGNOSIS NOTED AS PRIOR THORCOLUMBRAL SACRAL FUSION WITH FLATBACK DEFORMITY, PROXIMAL JUNCTION KYPHOSIS AND PSEUDOARTHROSIS. OPERATIVE REPORT INDICATED THE PATIENT HAD SIGNIFICANT SAGITTAL PLANE DEFORMITY WITH A PRIOR INSTRUMENTED FUSION FROM T9-S1 WITH PSEUDOARTHROSIS WITH A LOOSENING OF SOME IMPLANTS COMBINED WITH HYPOLORDOSIS LED TO SEVERE MISALIGNMENT. IMPLANTS FROM THE INDEX PROCEDURE WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603453 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention PEDICLE SCREWS, DBM