BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1639937 · Received March 23, 2010

    Report

    Report Number
    1030489-2010-00382
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    March 1, 2010
    Report Date
    February 25, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: OETGEN ET AL. COMPLICATIONS ASSOCIATED WITH THE USE OF BONE MORPHOGENETIC PROTEIN IN PEDIATRIC PATIENTS. J PEDIATRIC ORTHOP 2010;30:192-198. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADD'L DEVICE INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEDIATRIC PT UNDERWENT A POSTERIOR SPINAL FUSION USING RHBMP-2/ACS. AT AN UNK TIME POST-OP, THE PT EXPERIENCED ABNORMAL WOUND DRAINAGE WHICH RESOLVED WITH LOCAL WOUND CARE WITHOUT LONG TERM SEQUELAE.

    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