BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1328168 · Received February 27, 2009

    Report

    Report Number
    1030489-2009-00215
    Event Type
    Other
    Date Received
    February 27, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 2, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE SUSPECT DEVICES IN USE ARE CATALOG # G86945540, LOT W06J3468; CATALOG # G86946540, LOT# W08C2174 AND W08F4065. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE LIKE DEVICES CATALOG # 86945540 AND 86946540, 510K # K042025 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE FOR SPONDYLOLISTHESIS AT L4/5 USING POSTERIOR FIXATION. IT WAS REPORTED THAT THE PEDICLE SCREW WAS MISPLACED AT RIGHT SIDE L4. THE SCREW REPORTEDLY PENETRATED TO THE FORAMEN. THE SURGEON REINSERTED THE PEDICLE SCREW, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PATIENT REPORTEDLY WAS DOING WELL POST OP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other