BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2072720 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00474
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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 A SINUS AUGMENTATION DUE TO EDENTULISM / ATROPHIC SINUS, AND PLACEMENT OF A DENTAL IMPLANT WITH RHBMP-2/ACS. 519 DAYS POST-OP, THE IMPLANT PLACED AT THE BMP-2 GRAFTED SITE LOOSENED.

    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 USA, INC M110901AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention