Adverse events reported after the use of recombinant human bone morphogenetic protein 2

Journal of Oral and Maxillofacial Surgery

Volumn 70, Issue 4, 2012, Pages 765-767

  Woo, Emily Jane ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

ALVEOLAR RIDGE; ARTICLE; CANCER SURGERY; CLEFT PALATE; DEVICE INFECTION; EDEMA; ERYTHEMA; FEMALE; FOOD AND DRUG ADMINISTRATION; GRAFT FAILURE; HUMAN; MANDIBLE CANCER; MANDIBLE FRACTURE; MANDIBLE RECONSTRUCTION; MAXILLOFACIAL SURGERY; MEDICAL DEVICE; ORAL SURGERY; PERIODONTIC DEVICE; POSTOPERATIVE INFECTION; POSTOPERATIVE PAIN; PSEUDARTHROSIS; SURGICAL TECHNIQUE; TREATMENT INDICATION; WOUND COMPLICATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALVEOLAR PROCESS; BONE MORPHOGENETIC PROTEIN 2; CLEFT PALATE; DATABASES AS TOPIC; DRUG MONITORING; GRAFT SURVIVAL; HUMANS; MANDIBULAR FRACTURES; MANDIBULAR NEOPLASMS; OFF-LABEL USE; ORAL SURGICAL PROCEDURES; PSEUDARTHROSIS; RECOMBINANT PROTEINS; RECONSTRUCTIVE SURGICAL PROCEDURES; REOPERATION; SURGICAL WOUND INFECTION; TRANSFORMING GROWTH FACTOR BETA; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859105670     PISSN: 02782391     EISSN: 15315053     Source Type: Journal    
DOI: 10.1016/j.joms.2011.09.008     Document Type: Article

References (3)

1. PMA P050053, original application http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pma.cfm Accessed September 1, 2011
2. https://www.infusebonegraft.com/omf-package-insert.pdf Accessed September 1, 2011
3. http://www.fda.gov/medicaldevices/deviceregulationandguidance/ postmarketrequirements/reportingadverseevents/ucm127891.htm Accessed September 1, 2011