BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2991316 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00690
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: SINGLE LATERAL VIEW SHOWING PARAMESH CAGE, PUSHED AND DISLODGED ANTERIOR TO UPPER VERTEBRAL BODY. RODS AND SCREWS SPAN CORPECTOMY LEVEL IN LUMBAR SPINE. BROKEN ROD CANNOT BE VERIFIED. BANDAGE SCISSORS ARE BEING HELD OVER CONSTRUCT TO DETERMINE ALIGNMENT.

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS SCREW BREAKAGE AT THE BASE OF THE BONE SCREW NECK, PRIOR TO THE START OF THE THREAD; THE REMAINING PORTION OF THE MAS BONE SCREW REMAINS IN THE PATIENT AND THEREFORE WAS NOT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION OF ADJACENT SURFACES TO FRACTURE AREA OF FRACTURE INITIATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. FRACTURE SURFACE EXAMINATION IDENTIFIED A MULTI-MODAL FRACTURE, WITH RATCHET AND BEACH MARKS EMANATING AWAY FROM THE ORIGIN OF INITIAL FRACTURE PROPAGATION, AS WELL AS INCREASED MATERIAL DISRUPTION AND RIVER LINES CONSISTENT WITH SUB-CRITICAL OVERLOAD ON ONE SIDE OF THE FRACTURE, AND DAMAGED SURFACE ON THE OTHER, FOLLOWED BY A SECOND AREA OF BEACH MARKS UNTIL ULTIMATE FAILURE OF THE IMPLANT. AFTER VISUAL AND OPTICAL EXAMINATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS; 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 THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN SCREW AND THE CAGE BECOMING DISLODGED. THE CONSTRUCT WAS EXTENDED AND THE SCREW HEADS WERE REMOVED. THE SCREW SHAFT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95475 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0204519W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention