BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2147876 · Received July 1, 2011

    Report

    Report Number
    1030489-2011-00851
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTS THAT WERE USED ARE PART# G75495540, LOT W08J3850, EXPIRATION DATE 10/09/2016; LOT 0006741W, EXPIRATION DATE 12/11/2016; PART G75496540, LOT 0123744W, EXPIRATION DATE 11/04/2018; LOT 0124386W, EXPIRATION DATE 11/11/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75495540, 75496540, 510K # K042025 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT W08J3850 IS 09/23/2010; THE MANUFACTURE DATE FOR 0006741W IS 12/23/2008; THE MANUFACTURE DATE FOR LOT 0123744W IS 11/12/2010; THE MANUFACTURE DATE FOR LOT 0124386W IS 11/19/2010. ACCORDING TO THE REPORT, THE EVENT IS NOT BELIEVED TO BE RELATED TO THE IMPLANT. THE STERILIZATION CERTIFICATION WAS 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 PROCEDURE AT T8/L2 TO IMPLANT POSTERIOR FIXATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 18 DAYS POST OP TO REMOVE THE IMPLANTS DUE TO POST OP INFECTION. REPORTEDLY THE PATIENT IS DOING WELL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA W08J3850

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention RODS, PEDICLES, SET SCREWS