BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3813711 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02526
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 2990822, LOT # H13D0383; PART # 5440030 (X4); PART # 1475501030 (X2); PART #54840005545; PART # 54840006535 (X2); 54840005540 (X1). (B)(4). MANUFACTURE DATE FOR LOT H13D0383 IS 04/18/2013. 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 PATIENT (WITH SPONDYLOLISTHESIS L5-S1) UNDERWENT A GIL PROCEDURE L5-S1 WITH SUBSEQUENT 360 DEGREE FUSION, POSTERIOR LUMBAR INTERBODY FUSION OF L5-S1 USING ALLOGRAFT BONE IN THE DISC SPACE FOLLOWED BY A VERTEBRAL BODY REPLACEMENT WITH ITS MEDULLARY PORTION FILLED WITH LOCAL AUTOGENOUS BONE GRAFT FROM THE RIGHT SIDE. POSTEROLATERAL FUSION BILATERALLY L5-S1 USING LOCAL AUTOGENOUS BONE GRAFT ON THE RIGHT SIDE, AND ON THE LEFT SIDE ALLOGRAFT BONE WITH BONE MARROW ASPIRATE. BILATERAL PEDICLE SCREW INSTRUMENTATION L5-S1 USING SCREWS AND RODS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. SIXTEEN DAYS POST-OP, THE PATIENT BEGAN TO HAVE SYMPTOMS AND WAS ADMITTED TO THE HOSPITAL TWO DAYS LATER WITH REDNESS AT THE OPERATIVE SITE AND MILD SWELLING OF THE LOWER BACK INCISION WITH NO DRAINAGE, AS NOTED BY THE NURSE PRACTITIONER. PATIENT HAD A LOW GRADE FEVER (101.2) AND A WBC OF 15,300. WOUND CULTURES WERE POSITIVE FOR STAPH AUREUS. THE PATIENT REMAINED HOSPITALIZED FOR 5 DAYS, AND RECEIVED ANTIBIOTIC COVERAGE (VANCOMYCIN AND ZOSYN) DURING THAT TIME. PATIENT WAS DISCHARGED AND SWITCHED TO ROCEPHIN 2MG TO BE CONTINUED FOR 6 WEEKS AT HOME. THE PATIENT RETURNED TO THE HOSPITAL 5 DAYS LATER AS AN OUTPATIENT FOR INCISION AND DRAINAGE. THE HCP REPORTED THAT THE OPERATING SURGEON DOES NOT THINK THE SUBJECT ALLOGRAFT CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290802 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization SCREWS, RODS, VB REPLACEMENT, BONEGRAFT