BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1962544 · Received January 18, 2011

    Report

    Report Number
    1030489-2011-00057
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    July 1, 2009
    Report Date
    December 20, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES HAVE BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE WEEK FOLLOWING SURGERY FOR L5-S1 FUSION WITH POSTERIOR ROD FIXATION AND ALLOGRAFT, THAT THE PATIENT DEVELOPED DRAINAGE FROM THE LUMBAR INCISION. PATIENT VISITED THE ER FOR WOUND CULTURE AND PUT ON ANTIBIOTIC. SHORTLY AFTER, THE PATIENT VISITED THE IMPLANTING SURGEON WHO DIAGNOSED AS WOUND DRAINAGE, PROBABLY SECONDARY TO SEROMA. IRRIGATION, DEBRIDEMENT, AND CLOSURE OF THE LUMBAR WOUND SEROMA PERFORMED. WOUND CULTURE WAS POSITIVE FOR (B)(6). DURING FOLLOW UP VISIT APPROXIMATELY TWO WEEKS POST THE IRRIGATION, DEBRIDEMENT, AND CLOSURE, THE SURGEON REPORTS THERE IS NO ERYTHEMA OR DRAINAGE, AND DOES NOT SEE ANY EVIDENCE OF WOUND INFECTION OR DEEP INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention RODS, PEDICLE SCREWS, SETSCREWS, ALLOGRAFT