BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2130375 · Received June 16, 2011

    Report

    Report Number
    1030489-2011-00740
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INC
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BRACHIAL PLEXOPATHY. 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT AN ATROPIC NON-UNION OF THE CLAVICLE USING RHBMP-2/ACS. AN UNKNOWN TIME POST-OPERATIVELY, THE PATIENT DEVELOPED A BRACHIAL PLEXOPATHY. NO ADDITIONAL INFORMATION WAS REPORTED.

    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 INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention