BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYLINE ONE LEVEL PLATE, 26MM

    MDR report key: 3852140 · Received June 5, 2014

    Report

    Report Number
    1526439-2014-11571
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK052552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PER INTERNATIONAL AFFILIATE, IT WAS REPORTED THAT THE SURGEON REVISED A SKYLINE PLATE PATIENT DUE TO INFECTION. THE PATIENT WAS FIRST OPERATED IN (B)(6) OF THIS YEAR AND DEVELOPED AN INFECTION. THE SURGEON HAD DIFFICULTY REMOVING THE PLATE AND THE ORTHOPEDIC SURGEON ON CALL CAME IN TO ASSIST. THEY PULLED ON THE PLATE AND THE CONSTRUCT CONSISTING OF ONE SKYLINE ONE LEVEL PLATE AND FOUR SKYLINE SELF-DRILLING SCREWS CAME OFF IN ONE PIECE. A SHAPED VG2 ALLOGRAFT WAS ADDED TO ONE OF THE VERTEBRAE TO FILL THE CAVITY. SURGERY WAS DELAYED 60 MINUTES AND PATIENT NEEDED EXTRA GRAFTS. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE ONE SKYLINE PLATE AND FOUR SKYLINE SELF-DRILLING SCREWS THAT WERE INVOLVED IN THE EVENT: 1526439-2014-11571; 1526439-2014-11572; 1526439-2014-11573; 1526439-2014-11574; 1526439-2014-11575.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329645 SKYLINE ONE LEVEL PLATE, 26MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention