BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6756263 · Received August 1, 2017

    Report

    Report Number
    1030489-2017-01840
    Event Type
    Injury
    Date Received
    August 1, 2017
    Report Date
    July 6, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 869-021, 510K# K040962 AND (B)(4) IS CLEARED FOR THE US. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: KYPHOSIS PROCEDURE: T9-SAI: POSTERIOR FUSION LEVELS IMPLANTED: T9-SAI REASON FOR REVISION SURGERY: ROD REPLACEMENT DUE TO ROD BREAKAGE IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, ROD WAS BROKEN. AS THE ROD OF RIGHT SIDE WAS BROKEN AT L4-L5, BOTH RODS WERE REPLACED WITH NEW ONE AND BONE GRAFT WAS CONDUCTED AT THE AREA OF THE ROD BREAKAGE. FOUR RODS WERE ADDED AROUND THE BREAKAGE AREA AND THE REVISION SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537450 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0503023W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention