BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3893913 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02893
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 17, 2014
    Report Date
    August 15, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    MNI
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. NO MATERIAL SURFACE DEFECT NOTED IMMEDIATELY ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION IDENTIFIED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS (BEACH MARKS) APPROXIMATELY 30% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, AND SHEAR LIPS, WHICH ARE CONSISTENT WITH OVERLOAD 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; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE PATIENT STARTED EXERCISING WHEN THE ROD SNAPPED. THE PATIENT UNDERWENT A REVISION AND THE ROD WAS REPLACED. FUSION HAD NOT OCCURRED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371211 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION MNI WARSAW ORTHOPEDIC, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention