BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2850273 · Received November 29, 2012

    Report

    Report Number
    1030489-2012-02469
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 2, 2006
    Report Date
    August 2, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MICROSCOPIC AND SEM EXAMINATION OF THE SET SCREWS, MAS, AND RODS REVEALED A SIGNIFICANT AMOUNT OF PITTING PRESENT ON THE SET 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 U-CHANNEL, THE SET SCREW THREADS, AND THE SET SCREW BOTTOM FACE AND THE SPINAL ROD. THE CORRODED AREAS SEEN UNDER MICROSCOPIC AND 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. (B)(4). ONLY THE SET SCREWS WERE EXAMINED UNDER HIGH MAGNIFICATION VIA SEM, DUE TO SEM CHAMBER SIZE CONSTRAINTS. SEM MICROSCOPY IDENTIFIED CUBOIDAL PITTING /VOIDS SEEN ON MULTIPLE SET SCREW ROD INTERFACE SURFACES; SAMPLES APPEAR CONSISTENT IN LOCATION AND CORRODED SURFACE MORPHOLOGY TO CREVICE CORROSION. MICROSCOPIC EXAMINATION OF MAS HEADS AND ROD SURFACES IDENTIFIED CRYSTALLOGRAPHIC PITTING IN THE ROD SADDLE / MAS HEAD, CONSISTENT IN LOCATION AND SURFACE MORPHOLOGY WITH CREVICE 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 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

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# 7563535, LOT W06A0961; PART 7563530 LOT W05H2468; LOT W05H0636; W05H2464; PART 7563540, LOT W05K6130; PART 75645525, LOT W05A3163; PART 75645540, LOT W05M4793. DATE OF IMPLANT: 2006. (B)(6). (B)(4). PMA NUMBERS: 7563535, 7563530, 7563540, 510K K031655, 75645525, 75645540: 510K K042025. MANUFACTURE DATE FOR PART # 7563535 LOT W06A0961 IS 10/13/05; MANUFACTURE DATE FOR PART # 7563530, LOT W05H2468 IS 10/13/05; LOT W05H0636 IS 8/03/05; LOT W05H2464 IS 10/13/05; PART 7563540, LOT W05K6130 IS10/26/05; PART 75645525, LOT W05A3163 IS 1/18/05; PART 75645540, LIST W05M4793 IS 12/30/05. 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. APPROXIMATELY 4 YEARS POST-OP THE PATIENT UNDERWENT A CT SCAN AND FLUID WAS NOTICED. THE PATIENT UNDERWENT AN IRRIGATION/DEBRIDEMENT WOUND VAC. SIX YEARS POST-OP THE PATIENT UNDERWENT ANOTHER IRRIGATION DEBRIDEMENT. FUSION HAD OCCURRED SO THE HARDWARE WAS ALSO REMOVED. A WOUND VACUUM WAS APPLIED TO THE WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention