BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1032507 · Received April 18, 2008

    Report

    Report Number
    1030489-2008-00200
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE AT T7-T11 FOR T10 COMPRESSION FRACTURE USING POSTERIOR FIXATION. THE SCREWS AT T9 REPORTEDLY WERE PLACED INCORRECTLY AND DAMAGED A SPINAL CORD. THE REVISION SURGERY WAS PERFORMED IMMEDIATELY TO REMOVE THE SCREWS AT T9 AND REPLACE IT TO HOOKS. HOWEVER, THE PT SUFFERED PARALYSIS POST OP. IT WAS REPORTED THAT THE IMAGE WAS USED DURING THE PROCEDURE, BUT THE PICTURES WERE UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA W07G0359

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention