BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4673393 · Received April 9, 2015

    Report

    Report Number
    1030489-2015-00761
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    March 14, 2015
    Report Date
    June 2, 2015
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. NO SURFACE DEFECT NOTED ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION IDENTIFIED. FRACTURE SURFACE DAMAGE AND SMEARING IS NOTED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS (BEACH MARKS) APPROXIMATELY 50% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, RIVER LINES, AND SHEAR LIP, WHICH ARE CONSISTENT WITH OVERLOAD WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER TO BE WITHIN PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FORE GOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 848-011, 510K # K993810 WAS CLEARED IN THE UNITED STATES. 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 SURGICAL PROCEDURE AT T2-L3 TO TREAT EARLY ONSET SCOLIOSIS. THE PATIENT REPORTED HAVING PAIN AND IT WAS FOUND THAT THE LEFT SIDE ROD HAD BROKEN AROUND THE L1 LEVEL. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN ROD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237801 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R