BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3983721 · Received August 6, 2014

    Report

    Report Number
    1030489-2014-03401
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 MINIMALLY INVASIVE POSTERIOR LUMBAR FUSION AT T11-L3 TO TREAT A COMPRESSION FRACTURE AT L1. IT WAS REPORTED THAT THE SET SCREW WOULD NOT ENGAGE THE BONE SCREW. THE SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE TO GET THE SET SCREW TO ENGAGE AND FINISH FINAL TIGHTENING. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460407 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREW