BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3829779 · Received May 23, 2014

    Report

    Report Number
    1030489-2014-02607
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 5440030, #54840005540, #1475501055 AND # 1475501060. (B)(4). PMA/510K #S: K102555; PART # 54840005540, 510K K091974; 1475501055 AND 1475501060, 510K K113174 . 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 LUMBAR LAMINECTOMY AT L3, L4 AND L5. PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. PATIENT RETURNED TO EMERGENCY DEPARTMENT ONE MONTH POST-OP COMPLAINING OF LOW BACK PAIN SECONDARY TO SURGICAL WOUND. PATIENT DISCHARGED SAME DAY FROM ED. WOUND CULTURES TAKEN IN ED CAME BACK POSITIVE FOR (B)(6) AND PROTEUS. INFECTIOUS DISEASE DOCTOR INSTRUCTED PATIENT TO RETURN TO ED 5 DAYS LATER FOR IV ANTIBIOTICS AND I <(>&<)> D OF WOUND. I <(>&<)> D OF WOUND WAS COMPLETED ON 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307810 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention BONE SCREW, SET SCREW, RODS