BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3802377 · Received May 9, 2014

    Report

    Report Number
    1030489-2014-02453
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE COATING ON THE TRAILING SIDE OF THE SCREW'S THREADS APPEARS TO BE DAMAGED/COATING PEALED OFF. THIS KIND OF DAMAGE CAN OCCUR IF THERE IS PRESSURE PLACE ON THE SCREW AS IT IS BEING TIGHTEN DOWN (THE ROD NOT FULLY REDUCE IN SCREW HEAD). FUNCTIONALLY THE SCREW HAD NO PROBLEM GOING INTO A SAMPLE SCREW HEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440030, 510K # K102555 WAS CLEARED IN THE UNITED STATES. 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 SPINAL SURGICAL PROCEDURE AT T12-L5 TO TREAT DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT DURING INSERTION OF THE SET SCREW IN THE BONE SCREW, DEBRIS CAME OFF OF THE SET SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281909 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H13J3881

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW