BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1913896 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01531
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    December 17, 2009
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INC
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LOCALIZED ALVEOLAR RIDGE AUGMENTATION UTILIZING RHBMP-2/ACS CONCURRENT WITH SPACE MAINTENANCE DEVICES FOR SOFT TISSUE MANAGEMENT. IMMEDIATELY POST-OP,THE PATIENT DEVELOPED ERYTHEMA AND EDEMA. THE PATIENT'S SYMPTOMS WERE TREATED WITH MEDICATION, AND THE SYMPTOMS RESOLVED.

    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 NA M110804AAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention