BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1980431 · Received February 7, 2011

    Report

    Report Number
    1030489-2011-00100
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    November 17, 2010
    Report Date
    January 12, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT #0097569W, 0105686W. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # G869H021, 510K # K040962 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0097569W IS 06/11/2010, EXPIRATION DATE IS 06/01/2015; THE MANUFACTURE DATE FOR LOT 0105686W IS 07/23/2010, EXPIRATION DATE IS 07/16/2015. MULTIPLE FILMS OF COMPLEX PEDICLE SCREW FUSION T11-S1. LEFT S1 SCREW SHOWS INITIAL ROD PLACEMENT TOO SHORT TO CAPTURE S1 SCREW. POST-OP FILMS SHOW FLEXION OF CONSTRUCT ALLOWED DISSOCIATE OF SCREW AT S1 AND ROD. 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 X-RAYS SHOWED THE ROD BACKED OUT ON RIGHT SACRAL A WEEK POST OP. THE NUT REMAINED ON THE SCREW HEAD. REPORTEDLY, THE PATIENT IS ASYMPTOMATIC. HOWEVER, THE REVISION SURGERY MAY BE NEEDED.

    Description of Event or Problem · 1

    UPDATED INFORMATION: THE SECONDARY SURGERY WAS PERFORMED TWO MONTHS POST THE IMPLANTATION TO RE-POSITION THE BACKED OUT ROD. THE ROD WAS NOT REPLACED. 12 DAYS AFTER THE SECONDARY SURGERY, IT WAS FOUND THAT THE ROD ON THE RIGHT SACRAL BACKED OUT AGAIN. REPORTEDLY, THE PATIENT IS ASYMPTOMATIC. HOWEVER, THE THIRD SURGERY MAY BE NEEDED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention PEDICLE SCREWS, SET SCREWS