BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2080330 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00515
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8670855, 510K # K000453 WAS CLEARED IN THE UNITED STATES. VISUALLY AND OPTICALLY CONFIRMED THE THREAD CREST AND FLANKS ARE DAMAGED; THE LOCATION AND NATURE OF THE DAMAGE IS CONSISTENT WITH CROSS THREADING OF THE SET SCREW. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OPERATIONAL CONTEXT AND/OR INAPPROPRIATE SURGICAL TECHNIQUE, RESULTING IN THE FOREGOING EVENT. DEVICE HISTORY RECORDS 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 PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION. ONE OF THE SET SCREWS COULD NOT BE IMPLANTED DURING THE PROCEDURE. THE SURGEON REPLACED THE PEDICLE SCREW TO A NEW ONE TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA 0113762W

    Patients

    Seq Age Sex Outcome Treatment
    1