BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 6123612 · Received November 23, 2016

    Report

    Report Number
    1030489-2016-03226
    Event Type
    Injury
    Date Received
    November 23, 2016
    Report Date
    November 7, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A TH12-L2 FIXATION SURGERY DUE TO L1 BURST FRACTURE. ON AN UNKNOWN DATE, POST-OP, LOWEST INSTRUMENTED VERTEBRA (LIV) SCREWS (LEVEL L2) WAS BROKEN AT THE BASE OF THE SCREW. ON (B)(6) 2016, THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE IMPLANT.A PART OF THE SCREW COULD NOT BE REMOVED AND REMAINED IN PATIENT POST THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775043 CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention