BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT X-SMALL KIT

    MDR report key: 1730086 · Received June 18, 2010

    Report

    Report Number
    1030489-2010-00820
    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 AN L2 PEDICLE SUBTRACTION OSTEOTOMY, T10-S1 POSTEROLATERAL SPINAL FUSION USING RHBMP-2/ACS PLUS POSTERIOR FIXATION. AT AN UNK TIME POST-OP, THE PT PRESENTED WITH SEVERE PAIN, SWELLING, ERYTHEMA AND TENDERNESS TO PALPATION AT THE SURGICAL SITE. THIRTEEN DAYS POST-OP, THE PT UNDERWENT A CT (COMPUTED TOMOGRAPHY) -GUIDED DRAINAGE FOR POTENTIAL INFECTION AND TO DECOMPRESS THE SWELLING AT THE SURGICAL SITE. INFECTION WAS RULED OUT WITH INTRAOPERATIVE CULTURES. A SEROUS FLUID WAS 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 80 YR Hospitalization| R TITANIUM PEDICLE SCREWS