BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4051854 · Received September 2, 2014

    Report

    Report Number
    1030489-2014-03603
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4). 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 POSTERIOR LUMBAR INTERBODY FUSION AT T5-T11. AFTER PLACEMENT OF THE RODS AND FINAL TIGHTENING OF THE SCREWS, THE PATIENT¿S MEP VALUES DROPPED. THE SURGEON CONSIDERED IT TRANSIENT AND THE INCISION WAS CLOSED. HOWEVER, THE MEP VALUES DID NOT IMPROVE, SO THE SURGEON DECIDED TO OPEN THE INCISION AGAIN TO REMOVE AND RE-CONTOUR RODS. THEREAFTER, A WAKE-UP TEST WAS PERFORMED AND BOTH OF THE PATIENT¿S LEGS MOVED. THE INCISION WAS THEN CLOSED; HOWEVER, THE MEP VALUES DID NOT CHANGE. IT WAS REPORTED THAT THE PATIENT RECOVERED AND HER CLINICAL COURSE WAS WELL THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532738 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Other BONE SCREW, SET SCREW