BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1551878 · Received November 24, 2009

    Report

    Report Number
    1030489-2009-01127
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    October 22, 2009
    Report Date
    October 27, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 75446540, 510K # K042025 WAS CLEARED IN THE UNITED STATES. DEVICE HISTORY RECORDS REVIEW IS IN PROGRESS. THE SCREWS REMAIN IMPLANTED, PRODUCT EVALUATION IS NOT POSSIBLE AT THIS TIME. TWO AXIAL CT SCAN IMAGE ARE PROVIDED OF UNKNOWN LUMBAR LEVEL. BILATERAL RODS ARE NOTED. INTERBODY DEVICE APPEARS TO BE OUT OF THE DISK 80% ON ONE VIEW AND COUNTERSUNK INTO DISC ON ANOTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF AND A PLF AT L2-L5 TO IMPLANT INTERBODY DEVICE AND POSTERIOR FIXATION. FIVE MONTHS POST OP, X-RAYS CONFIRMED THAT THE PEDICLE SCREWS AT L2 AND L5 WERE LOOSENED. FUSION REPORTEDLY WAS NOT COMPLETED. SOME SENSORY DISCOMFORT WAS REPORTED, OTHERWISE THE PATIENT WAS REPORTEDLY ASYMPTOMATIC. THE REVISION SURGERY IS SCHEDULED ON (B) (6) 2009. PATIENT'S DEGENERATIVE SCOLIOSIS AND ROTATED VERTEBRAL BODIES STILL REMAINED AFTER THE INDEX SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWP MEDTRONIC SOFAMOR DANEK NA H08H6800

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR H09A0746,| (THIS PART IS NOT APPROVED FOR USE IN THE US)| H08M1340,| PEDICLE SCREW: CATALOG# G75446545, LOT# H08M0779,| CAGE: CATALOG# G9081973, LOT# N155| H09A0747.