BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2221504 · Received August 24, 2011

    Report

    Report Number
    1030489-2011-01098
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: JENSEN ET. TRANS-SINUS DENTAL IMPLANTS, BONE MORPHOGENETIC PROTEIN 2, AND IMMEDIATE FUNCTION FOR ALL-ON-4 TREATMENT OF SEVERE MAXILLARY ATROPHY. J ORAL MAXILLOFACIAL SURGERY; 2011. (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 IN A LITERATURE PUBLICATION THAT TEN PATIENTS UNDERWENT TRANS-SINUS IMPLANT PLACEMENT AND SIMULTANEOUS BMP-2 SINUS FLOOR GRAFTING FOR IMMEDIATE PROVISIONAL LOADING. INSERTION TORQUE WAS MEASURED UPON IMPLANT PLACEMENT. PATIENTS WERE FOLLOWED UP FOR AT LEAST 1 YEAR AFTER FINAL RESTORATION WHEN EITHER A COMPUTED TOMOGRAPHY SCAN OR PANORAMIC RADIOGRAPH WAS OBTAINED AND ANALYZED FOR THE PRESENCE OF TRANS-SINUS PERI-IMPLANT BONE. HOUNSFIELD UNITS WERE RECORDED MID SINUS GRAFT. IN THE TEN PATIENTS, IMPLANT APICES SOMETIMES PERFORATED 1 TO 2MM INTO THE NASAL FOSSA BUT REMAINED COVERED WITH MUCOSA. THERE WAS NO INSTANCE OF NASOLACRIMAL DUCT DYSFUNCTION.

    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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other