BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4843216 · Received June 15, 2015

    Report

    Report Number
    1030489-2015-01184
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    April 20, 2015
    Report Date
    May 21, 2015
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    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 # 855-012, 510K # K981676 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE/ TECHNIQUE: POSTERIOR LUMBAR INTERBODY FUSION LEVELS: TH-8 TO ILLIAC IT WAS REPORTED THAT DURING POST-OP, FRACTURES OF TITANIUM RODS WERE NOTED AT LEFT L4/L5 AND RIGHT L3/L4, FOR WHICH REVISION SURGERY WAS PERFORMED TO REPLACE THESE RODS. NO FRAGMENT OF THE PRODUCTS REMAINED INSIDE THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387664 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention