BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1545097 · Received November 11, 2009

    Report

    Report Number
    1030489-2009-01054
    Event Type
    Malfunction
    Date Received
    November 11, 2009
    Report Date
    October 13, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 #8699120, 510K # K981676 WAS CLEARED IN THE UNITED STATES. 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. 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 MULTIPLE SPINAL PROCEDURES TO FUSE T4 TO ILIAC. THE POSTERIOR FIXATION WAS IMPLANTED AT T4-ILIAC. THE RODS WERE BROKEN AT LEFT L1-L2 AND RIGHT T11-12 AT UNKNOWN TIME AFTER THE LAST PROCEDURE. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY 16 MONTHS POST OP TO REVISE THE BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWP WARSAW ORTHOPEDIC INC. UNK W07M3258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention