BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2954896 · Received February 11, 2013

    Report

    Report Number
    1030489-2013-00437
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    K113174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL AND OPTICAL EXAMINATION OF THE MAS HEAD IDENTIFIED A PORTION OF THE FIRST THREAD ON ONE SIDE IS BROKEN OFF. THE BROKEN-OFF PORTION OF THE HEAD IS MISSING AND NOT RETURNED FOR ANALYSIS. IN ADDITION TO THE BROKEN OFF PORTION OF THE HEAD, THERE IS PLASTIC DEFORMATION IN AN UPWARD DIRECTION, CONSISTENT WITH CROSS THREADING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS HEAD AND SET SCREW DURING CONSTRUCT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SETSCREW WOULDN'T ENGAGE THE BONE SCREW DURING INSERTION. THE SETSCREW KEPT CROSS THREADING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58313 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0197805W

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW