INFUSE BONE GRAFT

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.