BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4346562 · Received December 19, 2014

    Report

    Report Number
    1030489-2014-04797
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 6, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NPZ
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: LEAL ET AL. EVOLUTION OF POSTOPERATIVE EDEMA IN ALVEOLAR GRAFT PERFORMED WITH BONE MORPHOGENETIC PROTEIN (RHBMP-2). CLEFT PALATE CRANIOFAC J. 2014 DEC 1. APRIL - OCTOBER 2012. UNIVERSITY OF SAO PAULO MEDICAL SCHOOL, SAO PAULO, BR 04140. (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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLICATION THAT A STUDY WAS CONDUCTED ON 150 INDIVIDUALS SUBMITTED TO ALVEOLAR GRAFT (AG) SURGERY AT THE HOSPITAL FOR REHABILITATION OF CRANIOFACIAL ANOMALIES AT UNIVERSITY OF SAO PAULO (HRAC-USP) BETWEEN APRIL AND OCTOBER 2012. IN ALL SURGERIES, THE CLEFT AREA WAS FILLED USING RHBMP-2. A SMALL KIT (TWO MEMBRANES) WAS USED FOR EACH CLEFT. EACH MEMBRANE WAS SOAKED WITH 1.4 ML OF RHBMP-2 SOLUTION AT A CONCENTRATION OF 1.5 MG/ML, ADDING UP TO 4.2 MG OF RHBMP-2 FOR EACH CLEFT THE FORM FOR DATA COLLECTION WAS FILLED PREOPERATIVELY AT THE MAXILLOFACIAL SURGERY SECTOR OF HRAC-USP, AND THE COMPLEMENTARY DATA WERE COLLECTED ON THE 4 DAYS AFTER AG SURGERY BY A SINGLE EXAMINER. MAXIMUM FACIAL EDEMA OCCURRED IN 72 INDIVIDUALS ON DAY 4, IN 62 INDIVIDUALS ON DAY 3, AND IN 13 INDIVIDUALS ON DAY 2. NO INDIVIDUAL PRESENTED MAXIMUM EDEMA ON DAY 1, AND ONE INDIVIDUAL DID NOT PRESENT FACIAL EDEMA THROUGHOUT THE EVALUATION PERIOD. FEMALE PATIENTS PRESENTED GREATER PERCENTAGE OF INCREASE IN THE BASAL FACIAL MEASUREMENT COMPARED TO THE MALE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835610 INFUSE BONE GRAFT BONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT NPZ MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other