BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1921615 · Received December 13, 2010

    Report

    Report Number
    1030489-2010-01583
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    January 5, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): LITERATURE CITATION: ANAND, ET AL. MID-TERM TO LONG-TERM CLINICAL AND FUNCTIONAL OUTCOMES OF MINIMALLY INVASIVE CORRECTION AND FUSION FOR ADULTS WITH SCOLIOSIS. NEUROSURG FOCUS. 2010; 28 (3): RHBPM-2, PEDICLE SCREWS. NO THERAPY OR IMPLANT DATES WERE GIVEN. THE DEVICE REMAINS IMPLANTED: A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IN A RETROSPECTIVE STUDY, CLINICAL DATA WAS REVIEWED FOR 28 CONSECUTIVE PATIENTS WHO UNDERWENT FUSION OVER THREE OR MORE LEVELS, AND HAD A MINIMUM OF ONE YEAR OF FOLLOW-UP. ALL PATIENTS HAD SEVERE PREDOMINANTLY LOW- TO MIDDLE-BACK PAIN. ALL PATIENTS HAD PARTICIPATED IN EXTENSIVE CONSERVATIVE THERAPIES WITHOUT ADEQUATE RELIEF OF THEIR SYMPTOMS BEFORE BEING CONSIDERED FOR SURGERY. THE MEAN AGE OF THE PATIENTS IN THE STUDY WAS 67.7 YEARS. THE PATIENTS UNDERWENT A SINGLE OR COMBINATION OF SURGICAL INTERBODY DISC RELEASE AND FUSION PROCEDURES: AXIALIF (AXIAL LUMBAR INTERBODY FUSION), DLIF (DIRECT LATERAL INTERBODY FUSION), OR XLIF (EXTREME LATERAL INTERBODY FUSION). THE AMOUNT OF RHBMP-2/ACS USED VARIED WITH SURGICAL TECHNIQUE AND LEVEL TREATED. FROM THE DATA PRESENTED, IT IS NOT POSSIBLE TO DETERMINE THE SURGICAL TECHNIQUE, LEVELS TREATED, OR RHBMP-2 DOSE FOR A SPECIFIC PATIENT. ALL PATIENTS MAINTAINED CORRECTION OF THEIR DEFORMITY AND WERE NOTED TO HAVE SOLID ARTHRODESIS ON PLAIN RADIOGRAPHS AT ONE YEAR FOLLOW-UP. INTRAOPERATIVELY, THIS PATIENT HAD A RETROCAPSULAR RENAL HEMATOMA THAT WAS CLOSED OFF. THE PATIENT LOST 2000ML OF BLOOD AND RECEIVED APPROPRIATE TRANSFUSIONS, WITH NO UNTOWARD SEQUELAE. NO OTHER DETAILS WERE MENTIONED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention