BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3087200 · Received May 1, 2013

    Report

    Report Number
    1030489-2013-01419
    Event Type
    Death
    Date Received
    May 1, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    NKB
    PMA / PMN Number
    K050439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2013. CONCOMITANT PRODUCTS: 70466560; 7041310; 7049855; 8690024; 75444530 ; 75444525; 75444525; 75445530; 7540020; 7541122; 8115545; 8115539; 8115530; 75755302; 7570955. (B)(6). (B)(4). LOCATION: HOSPITAL. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL CORRECTION OF DEFORMITY WITH SCREW AND ROD IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. AS THE PROCEDURE WAS COMPLETE AND THE SURGEON WAS STARTING TO SUTURE THE SUBCUTANEOUS TISSUE, IT WAS REPORTED THAT THE PATIENT SUFFERED A PULMONARY EMBOLISM AND PASSED AWAY. PATIENT HAD A HISTORY OF PREVIOUS SURGERIES, WAS A NON-WALKER WITH HYDROCEPHALUS WITH A VALVE, NEPHROTIC SYNDROME AND HEART ARRHYTHMIAS. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERE KYPHO-SCOLIOSIS WITH A 35 DEGREE PELVIC TILT. THERE IS NO EVIDENCE THAT THE DEATH IS DEVICE RELATED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189438 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDIC, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Death