BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6867798 · Received September 15, 2017

    Report

    Report Number
    1030489-2017-02049
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    January 5, 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. FOLLOWING DEVICES WERE INVOLVED: PART# , LOT#, QTY, 510K#, UPN; 55840007545, UNK, 2, K113174, (B)(4); 55840007550, UNK, 4, K113174, (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LATERAL INTERBODY FUSION SURGERY USING O-ARM AND STEALTH AT L4-S1. REPORTEDLY, POST-OP, THE PATIENT DEVELOPED RADICULOPATHY. THERE WAS NO MALFUNCTION WITH THE IMPLANT ITSELF OR THE INSTRUMENTS USED WHEN IMPLANTING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649644 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other