BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1740318 · Received June 23, 2010

    Report

    Report Number
    1030489-2010-00826
    Event Type
    Injury
    Date Received
    June 23, 2010
    Report Date
    May 26, 2010
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #869-022, 510K# K040962 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. 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 SURGICAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L2 TO ILIAC APPROX FOUR MONTHS POST OP. FUSION REPORTEDLY FAILED AT L5-S1. THE PT DID NOT COMPLAIN OF PAIN. THE REVISION SURGERY REPORTEDLY IS REQUIRED, BUT NO REVISION SURGERY IS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWP WARSAW ORTHOPEDIC INC. NA 0032624W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention IMPLANT| IMPLANT| PEDICLE SCREWS| SET SCREWS| IMPLANT:| PEDICLE SCREWS| IMPLANT:| SET SCREWS