BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2881083 · Received December 20, 2012

    Report

    Report Number
    1030489-2012-02900
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T12-L4 TO TREAT A L1 AND L3 TRAUMATIC BURST FRACTURE. IT WAS REPORTED THAT THE T12 SCREW BACKED OUT. THE PATIENT UNDERWENT A REVISION SURGERY 7 WEEKS POSTOP. THE PATIENT COMPLAINED OF BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11K4658

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention