BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 3963250 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03323
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    PMA / PMN Number
    K094025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TLIF SPINAL SURGERY THE IMPLANT FRACTURED A SMALL AMOUNT UPON IMPACTION. (LEVELS IMPLANTED: 1). FLUROCCOPY APPEARED TO CONFIRM THIS AS THE RADIOGRAPHIC MARKERS APPEARED SLIGHTLY DISTORTED. HEALTHCARE PROVIDER DEEMED IMPLANT STABLE AND INTACT AND LEFT INSITU. THE IMPLANT BROKE AND FRAGMENT OF DEVICE WAS LEFT INSIDE THE PATIENT. PATIENT IS ALIVE AND NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441125 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK USA, INC NA H5105576

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR