BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1020024 · Received March 27, 2008

    Report

    Report Number
    1030489-2008-00152
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR THORACIC DECOMPRESSION AND FUSION AT UNKNOWN LEVELS USING RHBMP-2/ACS AND LOCAL BONE. AT AN UNKNOWN TIME POST-OP, THE PATIENT WAS NOTED TO HAVE DEVELOPED A COLLECTION OF FLUID. SURGICAL DRAINAGE OF THE FLUID WAS UNDERTAKEN AT AN UNKNOWN TIME POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention