BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6854422 · Received September 11, 2017

    Report

    Report Number
    1030489-2017-02023
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    August 16, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. MULTIPLE DEVICES WERE USED IN THE SURGERY: PART #55840007545, LOT # UNK, QTY 4, 510K# K113174, (B)(4); 55840007550, UNK, 2, K113174, (B)(4); 1553201060, UNK, 2, K113174, (B)(4); 8115545, UNK, 1, K030840, (B)(4). 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION USING SCREWS, RODS, SET SCREWS AND CROSSLINK. POST-OP, PATIENT SUFFERED WITH RADICULOPATHY IN LEGS. NONE OF THE IMPLANTS MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635488 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other