BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1680665 · Received May 7, 2010

    Report

    Report Number
    1030489-2010-00612
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    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 CLEANED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR 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 PT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L2-S1. THE FIXATION ROD BROKE AT L5-S1 POST OP. THE REVISION SURGERY WAS PERFORMED APPROX A YEAR POST OP TO REPLACE THE ROD AND THE SCREW, THE FIXATION LEVEL WAS EXTENDED TO THE ILIAC. IT WAS CONFIRMED AT THE REVISION SURGERY THAT THE FUSION WAS COMPLETE AT L2-L4, BUT L5-S1 DID NOT FUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWQ WARSAW ORTHOPEDIC INC. NA W08H4170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREWS| EXPLANT:| IMPLANT: