BEUDAMED
    FDA Adverse Event Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2231824 · Received September 1, 2011

    Report

    Report Number
    1030489-2011-01114
    Date Received
    September 1, 2011
    Report Date
    November 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MICROSCOPIC AND SEM ANALYSIS OF THE RETURNED DEVICES REVEALED A SIGNIFICANT AMOUNT OF PITTING PRESENT ON THE SCREWS WHERE THEY INTERFACE WITH THE MAS THREADS, AS WELL AS AT THE BASE OF THE SET SCREW WHERE IT INTERFACES WITH THE ROD. THE PITTING/CORRODED LOCATIONS ARE COMPONENT INTERFACE POINTS, SPECIFICALLY THE MAS HEAD AND SET SCREW THREADS AND THE SET SCREW BOTTOM FACE AND THE SPINAL ROD. THE CORRODED AREAS SEEN UNDER SEM EXAMINATION APPEARED TO HAVE A STRIATED GRANULAR APPEARANCE WITH CUBICAL VOIDS. 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. ADDITIONAL MICROSCOPIC EXAMINATION OF THE RODS AND MAS HEADS IDENTIFIED CRYSTALLOGRAPHIC PITTING IN THE ROD SADDLE INTERFACE AREA/MAS HEAD, CONSISTENT IN LOCATION AND SURFACE MORPHOLOGY WITH CREVICE CORROSION. THE PRESENCE OF LARGE AMOUNTS OF BIOLOGICAL MATERIAL MAY HAVE GENERATED AN OXYGEN DEFICIENT REGION, RESULTING IN 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

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THAT THE IMPLANTS APPEARED TO HAVE RUST AND CORROSION ON THEM. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention (B)(4)