BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1963016 · Received January 18, 2011

    Report

    Report Number
    1030489-2011-00058
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 20, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO LEVEL POSTERIOR SPINAL SURGERY AT T11-L1 TO TREAT A BURST FRACTURE. THE PATIENT UNDERWENT A REVISION SURGERY 1 MONTH POST-OP DUE TO A BROKEN SCREW. UPON EXPLANTATION OF THE BONE SCREW, IT WAS NOTICED THAT THE TULIP HAD SEPARATED FROM THE SCREW. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC 0116088W

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention