BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2045905 · Received April 8, 2011

    Report

    Report Number
    1030489-2011-00391
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 811-323, 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 A SPINAL SURGERY TO IMPLANT POSTERIOR FIXATION AND INTERBODY DEVICE AT L4-L5. IT WAS FOUND THAT THE LOW PROFILE CROSSLINK WAS DISLOCATED AT UNKNOWN TIME POST OP. THE REVISION SURGERY WAS PERFORMED 5 WEEKS POST OP. REPORTEDLY, THE PEDICLE SCREW WAS REPLACED DURING THE REVISION SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED DURING AND AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA 0114042W

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention INTERBODY DEVICE, BONE SCREWS, SET SCREWS