BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3471890 · Received November 15, 2013

    Report

    Report Number
    1030489-2013-04526
    Event Type
    Injury
    Date Received
    November 15, 2013
    Date of Event
    September 3, 2013
    Report Date
    October 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. PART # 778270001; #778225555; #868-021. (B)(4). PART # 778270001, 510K K090390; #778225555, 510K K090390; #868-021 510K K040962. THE DEVICES HAVE 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

    VISUAL AND MICROSCOPIC EXAMINATION OF THE SET SCREWS, MAS, RODS, AND OTHER ASSOCIATED HARDWARE NOTED PITTING; THE PITTING/CORRODED LOCATIONS ARE NOTED AT COMPONENT INTERFACE POINTS. THESE CONSTRUCT INTERFACE POINTS, WHEN ASSEMBLED, WOULD PROVIDE CREVICES WHICH CAN PROMOTE IN VIVO CORROSION. 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 WITHIN THE MINUTE CREVICES OF THE CONSTRUCT WOULD TEND TO BE MORE VULNERABLE TO THIS TYPE OF ATTACK. THE PITTED AREAS SEEN UNDER MICROSCOPIC EXAMINATION ARE CONSISTENT CHEMICAL ATTACK DUE TO CREVICE CORROSION. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 14 MONTHS POST-OP DUE TO INFLAMED TISSUE SURROUNDING THE CONSTRUCT AND CORROSION ON THE ROD AND 2 SET SCREWS. THE IMPLANTS WERE REMOVED. IT WAS NOTED THAT THE SCREWS THAT WERE IMPLANTED DURING A LATER SURGERY TO EXTEND THE CONSTRUCT SHOWED NO SIGNS OF CORROSION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593027 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS SCREWS, SET SCREWS