BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1672617 · Received April 30, 2010

    Report

    Report Number
    1030489-2010-00594
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 A TOOTH EXTRACTION/AUGMENTATION PROCEDURE USING 0.7 CCS OF RHBMP-2/ACS AND TITANIUM MESH IN THE ANTERIOR MAXILLA. TWO DAYS POST OP, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR SEVERE SWELLING, EDEMA, AND SUSPICION OF INFECTION. THE INFECTION HAS NOT BEEN CONFIRMED. THE PATIENT WAS GIVEN IV FLUIDS IN THE EMERGENCY ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANT:| TITANIUM MESH IMPLANT