BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1842442 · Received September 17, 2010

    Report

    Report Number
    1030489-2010-01224
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    February 18, 2008
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: TUMIALAN ET AL. THE SAFETY AND EFFICACY OF ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH POLYETHERETHERKETONE SPACER AND RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2: A REVIEW OF 200 PTS. J. NEUROSURG SPINE 2008:529-535. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NEITHER THE DEVICE NOR IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    POSTOPERATIVE COMPLICATIONS WERE OBSERVED IN A RETROSPECTIVE REVIEW OF THE USE OF RHBMP-2 AND POLYETHERETHERKETONE (PEEK) SPACERS IN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). STANDARD SURGICAL APPROACH WAS USED. FOLLOWING DISCECTOMY AN APPROPRIATELY SIZED PEEK SPACER WAS FILLED WITH LOW-DOSE RHBMP-2-SOAKED COLLAGEN SPONGE AND IMPLANTED AT EACH SURGICALLY TREATED LEVEL. SURGICAL PLATE FIXATION WAS THEN PERFORMED. TWO PTS WHO HAD UNDERGONE 4-LEVEL ACDF DEVELOPED MILD DYSPHAGIA THAT DELAYED HOSPITAL DISCHARGE. ALL REPORTED COMPLETED RESOLUTION OF SWALLOWING DIFFICULTIES AT 6-WEEK FOLLOW-UP.

    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 Hospitalization