BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2082373 · Received May 9, 2011

    Report

    Report Number
    1030489-2011-00529
    Event Type
    Injury
    Date Received
    May 9, 2011
    Report Date
    April 14, 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). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8699070, 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 PROCEDURE AT T11-S1. IT WAS FOUND THAT BOTH RODS BROKE AT AROUND L1 APPROXIMATELY A YEAR POST OP. THE PATIENT COMPLAINED OF PAIN POST OP. THE REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA W08F3994

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention PEDICLE SCREWS AND SET SCREWS