BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2920036 · Received January 17, 2013

    Report

    Report Number
    1030489-2013-00155
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    September 5, 2012
    Report Date
    December 19, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K011508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    MACROSCOPIC AND OPTICAL EXAMINATION NOTED PLASTIC DEFORMATION AT THE TOP FACE OF THE DRIVER INTERFACE HEXALOBE FEATURES, BUT DID NOT REVEAL THREAD CREST OR FLANK DAMAGE. FUNCTIONAL EVALUATION WITH A SAMPLE M8 RMAS HEAD FOUND ALL ASSOCIATED RETURNED RBOSS'S WERE ABLE TO BE FULLY ENGAGED INTO THE RMAS HEAD WITHOUT ISSUE. AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, THE IMPLANTS APPEAR TO BE CAPABLE OF PERFORMING THEIR INTENDED FUNCTION.

    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 SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SET SCREW SLID DURING INSERTION INTO THE BONE SCREW. THE SCREW WAS REMOVED AND REPLACED WITH A NEW SET SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25469 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0066152W

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR BONE SCREW