BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4911422 · Received July 14, 2015

    Report

    Report Number
    1030489-2015-01446
    Event Type
    Injury
    Date Received
    July 14, 2015
    Report Date
    September 15, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: CT PROVIDED IS CORONAL/AXIAL CUTS. IMAGING PROVIDED SHOWS A PAUCITY OF BONE AT IMPLANT SITE. UNCLEAR WHAT IMPLICATING FOR GRAFTING AT THIS LOCATION ARE BASED ON HISTORY PROVIDED.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR RHBMP-2/ACS XXS KITS USED ON THREE DIFFERENT PATIENTS. POST-OP, ALL THE THREE PATIENTS CAME BACK WITHIN A PERIOD OF 8-10 MONTHS AND MINIMAL BONE WAS FORMED, BUT SKIN WAS HEALED. THE SURGEON REPORTED THIS EVENT BECAUSE THIS WAS A DIFFERENT REACTION THAN HE HAD EVER SEEN WITH HIS USE OF RHBMP-2/ACS IN HIS OMF PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456256 INFUSE BONE GRAFT BONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT NPZ MEDTRONIC SOFAMOR DANEK USA, INC NA M111306AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other