BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1920616 · Received December 13, 2010

    Report

    Report Number
    1030489-2010-01582
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    June 14, 2010
    Report Date
    November 23, 2010
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K061591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: HYNES, ET AL. CORTICAL BONE TRAJECTORY FOR LUMBAR PEDICLE SCREWS. TBD. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE WAS EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    EARLY RESULTS OF CLINICAL EXPERIENCE WITH A NEW MEDIAL SCREW TRAJECTORY INSERTION TECHNIQUE ARE GIVEN (THE PEDICLE SCREW TRAJECTORY IS ALTERED SO THAT THE SCREW IS DIRECTED THROUGH THE PEDICLE CORTICAL BONE ONLY). THE RETROSPECTIVE REVIEW OF PERI-OPERATIVE AND POST-OPERATIVE COMPLICATIONS INCLUDES CONSECUTIVE PATIENTS, AGE 18 OR OLDER, WHO UNDERWENT LUMBAR ARTHRODESIS AND HAD A MINIMUM 3-MONTH FOLLOW-UP. DATA WAS EXTRACTED FROM CHARTS AND HOSPITAL RECORDS. THERE WERE 107 PATIENTS WHO UNDERWENT BILATERAL PEDICLE SCREW FIXATION USING TRADITIONAL LATERAL INSERTION TECHNIQUE (LATERAL GROUP) AND 314 PATIENTS WHO UNDERWENT BILATERAL PEDICLE SCREW FIXATION USING THE NEW MEDIAL TRAJECTORY INSERTION TECHNIQUE (MEDIAL GROUP). SCREW-ROD INTERFACE FAILURES WERE REPORTED IN TWO MEDIAL GROUP PATIENTS. NO DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1