BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM

    MDR report key: 8765786 · Received July 6, 2019

    Report

    Report Number
    2246640-2019-00006
    Event Type
    Injury
    Date Received
    July 6, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 6, 2019
    Manufacturer
    MEDTRONIC EATONTOWN
    Product Code
    NUN
    PMA / PMN Number
    SEE H10
    Adverse Event
    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 UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # T43105, 510K #K051188, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. 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. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT C2-T2 POSTERIOR FIXATION AND C2-7 LAMINOPLASTY WITH IMPLANTABLE HARDWARE AND BONE GRAFTING MATERIAL. POST-OP, WETTING LIQUID (UNCLEAR AND SLIGHTLY YELLOWISH LIQUID) ACCUMULATED IN 2 WEEKS AFTER THE OPERATION, AND EVEN THE LIQUID WAS REMOVED, IT ACCUMULATED AGAIN. ALSO, SITE WHERE THE PRODUCTS IMPLANTED WAS SWELLED. THERE WAS NO SYMPTOMS OF INFECTION. AN OPERATION, TO REMOVE THE WETTING LIQUID, WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559468 GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE NUN MEDTRONIC EATONTOWN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R