BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1972840 · Received January 28, 2011

    Report

    Report Number
    1030489-2011-00079
    Event Type
    Injury
    Date Received
    January 28, 2011
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SWELLING OF RIGHT CHEEK 6 WEEKS POST BILATERAL SINUS SURGERY. THE PATIENT WAS PRESCRIBED A COMBINATION OF TWO DIFFERENT ANTIBIOTICS AND AN INCISION AND DRAINAGE WAS PERFORMED, WHICH REDUCED THE SYMPTOM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL SINUS LIFT PROCEDURE. THE PATIENT HAD MCBA AND RHBMP-2/ACS IMPLANTED ON THE RIGHT SIDE, AND MCBA AND RHBMP-2/ACS IMPLANTED ON THE LEFT SIDE. 6 WEEKS POST-OP, THE PATIENT HAD SWELLING OF THE RIGHT CHEEK. THE PATIENT WAS PRESCRIBED A COMBINATION OF TWO DIFFERENT ANTIBIOTICS AND HAD AN INCISION AND DRAINAGE PERFORMED WHICH REDUCED THE SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)