BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3193017 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02585
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K981676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT UNDERWENT A LUMBAR DISC POSTERIOR FIXATION SURGERY ON. WHEN THE PATIENT HAD X-RAY TEST BEFORE DISCHARGE, DOCTOR FOUND ONE OF SETSCREWS EXTRUDED FROM THE ROD. DOCTOR PERFORMED A REVISION SURGERY 9 DAYS POSTOP. DURING THE SURGERY, DOCTOR FOUND THREE SET SCREWS EXTRUDED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294585 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13B1923

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention