BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3010470 · Received March 19, 2013

    Report

    Report Number
    1030489-2013-00776
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 6, 2008
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT. PRESENTED FOR SURGERY WITH CHRONIC BACK AND LEG PAIN, LUMBAR RADICULOPATHY, AND LUMBAR STENOSIS, AND UNDERWENT A PROCEDURE FOR LAMINECTOMY OF L3, 4, AND 5, POSTERIOR LUMBAR INTERBODY FUSION, POSTERIOR HARDWARE FROM L3-SACRUM AND A POSTEROLATERAL FUSION. APPROXIMATELY 3 WEEKS POST-OP THE PT. PRESENTED TO THE ER WITH FEVER, AND SWELLING, PAINFUL WOUND. PT. UNDERWENT EMERGENCY I AND D FOR SUSPECTED WOUND INFECTION. WOUND CULTURES AND BLOOD CULTURES GREW (B)(6). PT. WAS PLACED ON IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113675 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention PEEK CAGE,PEDICLE SCREWS,BCP,ALLOGRAFT,AUTOGRAFT