BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1961815 · Received January 14, 2011

    Report

    Report Number
    1030489-2011-00047
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 17, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROD HAS 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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE POSTERIOR SIDE OF THE RODS PRESENTS SEVERAL CONTACTS WITH THE SETSCREWS (9 CONTACTS PER ROD). ONE PART OF THE BROKEN ROD PRESENTS TYPE OF CORROSION BETWEEN TWO FAS. THIS TYPE OF CORROSION IS NOT LINKED TO THE ROD BREAKAGE. THE ANTERIOR SIDE OF THE RODS PRESENTS SEVERAL CONTACTS WITH THE FAS ROD CANALS. BOTH RODS PRESENT DEEP SCRATCHES AT THE BENDING AREA COMING FROM THE IN-SITU BENDERS. ONE ROD BROKE AT ONE OF THESE SCRATCHES. THE FRACTURE APPEARANCE IS TYPICAL OF A FATIGUE STARTING FROM THE POSTERIOR SIDE OF THE ROD AND PROPAGATING ANTERIORLY THROUGH A SECTION PERPENDICULAR TO THE ROD. SOME PORTIONS OF THE FRACTURE ARE WORN DUE TO FRICTION WITH THE OPPOSITE SECTION OF THE BROKEN ROD. NO DEFECT OF THE MATERIAL WAS FOUND AT THE LEVEL OF THE BROKEN SECTION. NO DEFECTS WERE FOUND ON THE RETURNED IMPLANTS THAT COULD BE RESPONSIBLE OF THE BREAKAGE. THE ROD BREAKAGE IS TYPICAL OF A FATIGUE BREAKAGE DUE TO CYCLIC FLEXURAL SOLICITATION OF THE ROD. IN ADDITION, THE BREAKAGE INITIATED AT THE LEVEL OF AN IMPACTION DUE TO THE USE OF IN-SITU BENDERS, WHICH CAN REDUCE THE FATIGUE STRENGTH OF THE MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION SURGERY FROM T7 TO L5 USING POSTERIOR FIXATION TO CORRECT SCOLIOSIS. PER THE INITIAL REPORTER, IT WAS A STRONG CORRECTION OF SCOLIOSIS. AN UNKNOWN TIME POST-OP, THE ROD BROKE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN ROD AND IMPLANT A LARGER ROD IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. 0064597W

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention