BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 6550925 · Received May 8, 2017

    Report

    Report Number
    1030489-2017-01141
    Event Type
    Injury
    Date Received
    May 8, 2017
    Report Date
    August 3, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: X-RAY IMAGE REVIEW. X-RAY REVIEW: "POST OP X-RAYS DEMONSTRATE A MULTI LEVEL FUSION CONSTRUCT IN A PATIENT WITH MULTIPLE COMPRESSION DEFORMITIES PRESUMABLY FOR OSTEOPOROSIS. ON PROVIDED IMAGES THERE IS A DISCONNECTION AT THE CONNECTOR BETWEEN THE LUMBOSACRAL AND THORACOLUMBAR SEGMENTS OF THE CONSTRUCT. GIVEN THE BONE QUALITY IT IS NOT SURPRISING THAT THIS CONSTRUCT FAILED AS BONY FUSION WILL BE SLOW TO OCCUR."

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 778116565, 510K# K090390 AND UDI (B)(4) IS APPROVED FOR SALE IN U.S. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL, OPTICAL AND MICROSCOPIC EXAMINATION OF THE SET SCREW FACE IDENTIFIED HEAVY WITNESS MARKS ON THE PERIPHERY, ANGLED NODE MORPHOLOGY, AND ASYMMETRICAL ROD-SET SCREW WITNESS MARKS; ADDITIONALLY, COMPARATIVELY LIGHT WITNESS MARKS ON ONE OF THE CORRESPONDING RODS IS NOTED. THESE OBSERVATIONS ARE CONSISTENT WITH ANGULATED ROD IN THE MRC WHICH CONTRIBUTED TO INCOMPLETE SEATING OF THE SET SCREW AND SUBSEQUENT SCREW BACK-OUT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PATIENT UNDERWENT A FIXATION SURGERY IN WHICH FIXATION LEVELS WERE EXTENDED DUE TO ILIAC AND ROD CONNECTION WAS CARRIED OUT WITH MRC. APPROX. ONE MONTH AFTER THE OPERATION, THE RODS ON BOTH SIDES OF CAUDAL PORTION WERE DISLOCATED FROM THE CONNECTORS. THERE SEEMS TO BE SLIGHT GAP BETWEEN THE ROD ON THE LEFT SIDE AND MRC. IT IS POSSIBLE CAUSE OF THE EVENT. REVISION SURGERY IS PLANNED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333185 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0451961W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention