BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT X SMALL KIT

    MDR report key: 1725373 · Received June 11, 2010

    Report

    Report Number
    1030489-2010-00792
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    January 14, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). A REVIEW OF THE CERTIFICATE 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. NEITHER 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 THE PT UNDERWENT SURGERY ON (B) (6) 2009 IN THE TOOTH #18-19 AREA TO GROW BONE USING RHBMP-2ACS. PT HAD PRE-OP ANTIBIOTICS, AND A FULL COURSE OF ANTIBIOTICS POST-OP. THE PT REPORTED PAIN POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT X SMALL KIT INFUSE BONE GRAFT NPZ MEDTRONIC SOFAMOR DANEK NA M110814AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR IMPLANTED| EXPLANTED| ENDOBOND