BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2105792 · Received May 27, 2011

    Report

    Report Number
    1030489-2011-00637
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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 # 84505HT, 510K # K981676 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IN ADDITION, THE DEVICE MET ITS INTENDED FUNCTION BY SUPPORTING FUSION. 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 PATIENT UNDERWENT A THIRD SURGERY TO EXTEND THE POSTERIOR FIXATION TO T6 (PREVIOUS FIXATION WAS FROM T9-S1). THE DOMINO'S LOCK SCREW COULD HAVE BEEN LOOSENED AND THE DEBRIS WAS OBSERVED WHILE EXPLANTING IT. THE DEBRIS WAS REMOVED FROM THE PATIENT. THE DOMINO CONNECTOR WAS REMOVED. REPORTEDLY, THE FUSION OCCURRED AT THE PREVIOUS FIXATION LEVELS HOWEVER IT IS UNKNOWN WHICH LEVEL WAS COMPLETELY FUSED. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA 0000737W

    Patients

    Seq Age Sex Outcome Treatment
    1