BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT X-SMALL KIT

    MDR report key: 1730071 · Received June 18, 2010

    Report

    Report Number
    1030489-2010-00815
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    December 5, 2009
    Report Date
    May 25, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE CITATION: GARRETT ET AL, "FORMATION OF PAINFUL SEROMA AND EDEMA AFTER THE USE OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 IN POSTEROLATERAL LUMBAR SPINE FUSIONS" IN NEUROSURGERY (2010; 66: 1044-1049). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A L3-S1 POSTERIOR SPINAL FUSION, REVISION OF PREVIOUS FUSION USING RHBMP-2/ACS PLUS POSTERIOR FIXATION. AT AN UNK TIME POST-OP, THE PT PRESENTED WITH INCISIONAL DRAINAGE, SWELLING, ERYTHEMA AND TENDERNESS TO PALPATION AT THE SURGICAL SITE. SEVEN DAYS POST-OP, THE PT UNDERWENT AN EXPLORATORY SURGERY FOR POTENTIAL INFECTION AND TO DECOMPRESS THE SWELLING AT THE SURGICAL SITE. INFECTION WAS RULED OUT WITH INTRAOPERATIVE CULTURES. THE SUBCUTANEOUS TISSUES WERE EDEMATOUS AND NOTED TO BE "SEEPING" WHEN THE RETRACTORS WERE PLACED. A SUBFASCIAL SEROMA WAS ENCOUNTERED AND DRAINED. THE SEROMA DID NOT RE-FORM AFTER THE SECOND SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R TITANIUM PEDICLE SCREWS