BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3161992 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02148
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 13, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS ROD BROKEN APPROX. ~75MM FROM END OF ROD. MULTIPLE ROD BENDER POINTS AND SET SCREW WITNESS MARKS NOTED ALONG THE LENGTH OF BOTH RODS. NO SURFACE DEFECT THAT APPEARS TO HAVE CONTRIBUTED TO CRACK INITIATION AND PROPAGATION IDENTIFIED. FRACTURE SURFACE DAMAGE AND NOTED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS OR BEACH MARKS APPROXIMATELY 50% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, RIVERLINES, AND SHEAR LIPS, WHICH ARE CONSISTENT WITH OVERLOAD TO WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER BOTH ABOVE AND BELOW THE FRACTURE 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 FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4): THE RODS 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

    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 POSTERIOR SPINAL SURGERY TO TREAT KYPHOSIS AT L2-3. APPROXIMATELY 2 YEARS POST-OP THE PATIENT UNDERWENT A SECOND SURGERY TO TREAT A L1 COMPRESSION FRACTURE AND FRACTURES AT L2, L3, L4 WITH INSTRUMENTATION AT T8-ILIAC. IT WAS REPORTED THAT SOMETIME POST-OP THE RODS BROKE BETWEEN L3 AND L4. THE PATIENT UNDERWENT A REVISION SURGERY 10 MONTHS POST-OP. THE RODS AND ILIAC SCREWS WERE REPLACED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262840 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0197578W

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention