BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1822662 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01105
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    July 30, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    NA
    Removal / Correction Number
    1030489-122107-009R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL FUSION SURGERY USING POSTERIOR FIXATION. AN UNK TIME POST-OP, IT WAS REPORTED THAT A ROD BROKE DUE TO A LYTIC SPONDYLOLISTHESIS. THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention