BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5537156 · Received March 31, 2016

    Report

    Report Number
    1030489-2016-00848
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    June 20, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: LIANG, FAN MD; YEN, STEPHEN DMD, PHD; FLORENDO, ELLYNORE BS; URATA, MARK MD, DDS; HAMMOUDEH, JEFFERY MD, DMD; "3D CONE BEAM COMPUTED TOMOGRAPHY VOLUMETRIC OUTCOMES OF RHBMP-2/ DEMINERALIZED BONE MATRIX VS. ILIAC CREST BONE GRAFT FOR ALVEOLAR CLEFT RECONSTRUCTION". (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLICATION "3D CONE BEAM COMPUTED TOMOGRAPHY VOLUMETRIC OUTCOMES OF RHBMP-2/DEMINERALIZED BONE MATRIX VS. ILIAC CREST BONE GRAFT FOR ALVEOLAR CLEFT RECONSTRUCTION" THAT 34 PATIENTS UNDERWENT SECONDARY ALVEOLAR CLEFT REPAIR. IN 21 PATIENTS RHBMP-2 ENCASED IN DEMINERALIZED BONE MATRIX SCAFFOLD (MS) WAS USED. POST-OP, MOST COMMON COMPLICATION WAS INCREASED LOCAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194758 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other