BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2972840 · Received February 21, 2013

    Report

    Report Number
    1030489-2013-00592
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND MICROSCOPIC EXAMINATION OF MAS HEAD IDENTIFIED CRYSTALLOGRAPHIC PITTING IN THE MAS HEAD ROD SADDLE AREA, CONSISTENT IN LOCATION AND SURFACE MORPHOLOGY WITH CREVICE CORROSION. ADDITIONALLY, CRACKS ARE NOTED APPROXIMATELY 120 DEGREES APART AT THE BASE OF THE MAS HEAD. THE CORRODED AREA SEEN UNDER MICROSCOPIC EXAMINATION HAS A GRANULAR APPEARANCE. THESE VOIDS ARE INDICATIVE OF CHEMICAL ATTACK. THE PITTING SEEN AT THESE CONSTRUCT INTERFACE POINTS, WHEN ASSEMBLED, WOULD PROVIDE CREVICES WHICH CAN PROMOTE IN VIVO CORROSION. (B)(4). STAINLESS STEEL CORROSION RESISTANCE IS OBTAINED FROM A PASSIVE FILM WHICH FORMS IN AN OXYGEN RICH ENVIRONMENT; THE PRESENCE OF LARGE AMOUNTS OF BIOLOGICAL MATERIAL MAY HAVE GENERATED AN OXYGEN DEFICIENT REGION, RESULTING ANODIC CELL DEVELOPMENT, WHICH WOULD RESULT IN THE LOSS OF THE PASSIVE FILM AND EVENTUAL CORROSION OF THE MATERIAL. ADDITIONALLY, MICRO-MOTION OF THE COMPONENTS MAY HAVE ALSO CONTRIBUTED BY MECHANICALLY REMOVING THE PASSIVE FILM FORMED ON THE STAINLESS STEEL. THE NATURE, LOCATION, AND CORRODED SURFACE MORPHOLOGY OF THE RETURNED IMPLANTS ARE CONSISTENT WITH ANTICIPATED IN-VIVO WEAR DUE TO CREVICE CORROSION.

    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 FUSION TO CORRECT A SCOLIOTIC DEFORMITY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACK PAIN 2.5 YEARS POST-OP. ARTHROSIS WAS CONFIRMED BY THE SURGEON AND ALL IMPLANTS WERE EXPLANTED. IT WAS NOTED THAT THERE WAS A BLACK CRUST-LIKE CORROSION ON ONE OF THE EXPLANTED BONE SCREWS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75526 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H09K5989

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention