BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2020724 · Received March 16, 2011

    Report

    Report Number
    1030489-2011-00288
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROUTINE RIDGE AUGMENTATION VIA A SINUS LIFT PROCEDURE USING RHBMP-2/ACS. THREE DAYS POST-OP, THE PATIENT BEGAN HAVING A SEVERE SWELLING REACTION. THE PATIENT COMPLAINED OF PAIN AND THERE WAS SWELLING THAT CAUSED THE SURGEON TO RE-OPEN THE INCISION AND LOOK AT THE RESIDUAL ACS. NO PURULENCE AND NO ABNORMALITY WAS DETECTED. THE SITE WAS NOT CULTURED AS, PER THE SURGEON, THERE WAS NOTHING TO CULTURE. THE PATIENT THEN WENT TO SEE AN ENT. PER THE SURGEON, THE ENT DID NOT FIND ANY SUBSTANTIVE ISSUE AND RECOMMENDED OBSERVATION. PER THE PATIENT, ONE MONTH POST-OP THE ENT REMOVED A MASS FROM THE IMPLANTATION SITE DUE TO THE SWELLING.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R