BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3970518 · Received July 31, 2014

    Report

    Report Number
    1030489-2014-03376
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL REVIEW CONFIRMS ONE SIDE OF FIXED ANGLE SCREW HEAD IS BROKEN OFF AND NOT RETURNED FOR ANALYSIS. THE UNBROKEN SIDE OF THE FAS HEAD REVEALS FAS HEAD THREAD FLANK AND CREST DAMAGE. ON THE BROKEN SIDE FRACTURE APPEARS TO HAVE INITIATED NEAR THE BASE OF THE THREAD ROOT AND PROPAGATED CROSS-SECTIONALLY THROUGH THE IMPLANT; THE DIRECTION OF MATERIAL DEFORMATION AND FRACTURE IS CONSISTENT WITH BEND STRESS OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH SUGGEST BEND STRESS OVERLOAD DURING INTRAOPERATIVE ASSEMBLY.

    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 POSTERIOR SPINAL SURGICAL PROCEDURE AT T2-T12 TO TREAT SCOLIOSIS. IT WAS REPORTED THAT DURING FINAL TIGHTENING THE SCREW HEAD BROKE OFF. THE SET SCREWS HAD TO BE REMOVED FROM ALL OF THE BONE SCREWS TO REMOVE THE ROD AND REPLACE THE BROKEN SCREW. SURGICAL TIME WAS EXTENDED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447850 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11F4180

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR ROD, SET SCREW