BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYTEM

    MDR report key: 3815263 · Received May 16, 2014

    Report

    Report Number
    1030489-2014-02546
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. 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 # 54840006535, #54840006540, #54840007535, #5440030 AND #2991022, LOT # H13K0599. (B)(4). LOCATION : HOSPITAL . PART #S: 54840006535, #54840006540, #54840007535 - 510K K091974; 5440030 ¿ 510K K102555; 2991022 ¿ 510K K073291. MANUFACTURE DATE FOR LOT H13K0599 IS 10/09/2013. 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 UNDERWENT A REVISION OF A POSTERIOR LAMINECTOMY AND FUSION AT L5-S1 WITH REMOVAL OF HARDWARE. APPROXIMATELY 19 DAYS POST OP, THE PATIENT NOTICED SIGNS OF INFECTION. THE PATIENT HAD FEVER, FATIGUE AND BACK PAIN. WOUND CULTURES WERE TAKEN WHICH FOUND (B)(6). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR IRRIGATION AND DEBRIDEMENT OF THE LUMBAR SPINE WOUND. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER AND CONTINUED IV INFUSIONS AT HOME FOR 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293370 CD HORIZON SPINAL SYTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention RODS, SCREWS, VB REPLACEMENT,