Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures general

Clinical Orthopaedics and Related Research

Volumn 471, Issue 5, 2013, Pages 1707-1711

  Woo, Emily Jane ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

INFUSE; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; UNCLASSIFIED DRUG;

BONE REMODELING; COMPARTMENT SYNDROME; CONGENITAL PSEUDARTHROSIS; CONGENITAL PSEUDARTHROSIS TIBIA; CONTROLLED STUDY; FOOD AND DRUG ADMINISTRATION; HETEROTOPIC BONE; HETEROTOPIC OSSIFICATION; HUMAN; HUMERAL RECONSTRUCTION; INFLAMMATION; MAJOR CLINICAL STUDY; NONSPINAL ORTHOPEDIC SURGERY; ORTHOPEDIC SURGERY; OSTEOLYSIS; PERIPHERAL NERVE INJURY; PRIORITY JOURNAL; PSEUDARTHROSIS; RANGE OF MOTION; REVIEW; SIDE EFFECT; SURGICAL INFECTION; SURGICAL TECHNIQUE; TIBIA FRACTURE; TIBIA PLATEAU FRACTURE; TREATMENT CONTRAINDICATION; WOUND COMPLICATION;

EID: 84876664953     PISSN: 0009921X     EISSN: 15281132     Source Type: Journal    
DOI: 10.1007/s11999-012-2684-x     Document Type: Review

References (11)

1. Govender S, Csimma C, Genant HK, Valentin-Opran A, Amit Y, Arbel R, Aro H, Atar D, Bishay M, Börner MG, Chiron P, Choong P, Cinats J, Courtenay B, Feibel R, Geulette B, Gravel C, Haas N, Raschke M, Hammacher E, van der Velde D, Hardy P, Holt M, Josten C, Ketterl RL, Lindeque B, Lob G, Mathevon H, McCoy G, Marsh D, Miller R, Munting E, Oevre S, Nordsletten L, Patel A, Pohl A, Rennie W, Reynders P, Rommens PM, Rondia J, Rossouw WC, Daneel PJ, Ruff S, Rüter A, Santavirta S, Schildhauer TA, Gekle C, Schnettler R, Segal D, Seiler H, Snowdowne RB, Stapert J, Taglang G, Verdonk R, Vogels L, Weckbach A, Wentzensen A, Wisniewski T; BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) Study Group. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am. 2002;84:2123-2134.
2. Medtronic Sofamor Danek USA, inc. Available at: https://www. infusebonegraft.com/trauma-package-insert.pdf. Accessed October 2, 2012.
3. Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health. 1995;85:1706-1709.
4. Salas M, Hofman A, Stricker BH. Confounding by indication: an example of variation in the use of epidemiologic terminology. Am J Epidemiol. 1999;149:981-983.
5. Sills JM, Tanner LA, Milstien JB. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm. 1986;43:2764-2770.
6. US Food and Drug Administration. Available at: http://www.accessdata.fda. gov/cdrh-docs/pdf/P000054a.pdf. Accessed October 2, 2012.
7. US Food and Drug Administration. Summary of Safety and Effectiveness Data. Available at: http://www.accessdata.fda.gov/cdrh-docs/pdf/P000054b.pdf. Accessed October 2, 2012.
8. US Food and Drug Administration. Premarket Approval (PMA). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm (PMA P000054, supplements S009 and S016). Accessed October 2, 2012.
9. US Food and Drug Administration. How to Market Your Device: Humanitarian Device Exemption. Available at: http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ HumanitarianDeviceExemption/default.htm. Accessed October 2, 2012.
10. US Food and Drug Administration. Medical Devices: Manufacturer and User Facility Device Experience Database - (MAUDE) Available at: http://www.fda.gov/ medicaldevices/deviceregulationandguidance/postmarketrequirements/ reportingadverseevents/ucm127891.htm. Accessed October 2, 2012.
11. Verstraeten T, Baughman AL, Cadwell B, Zanardi L, Haber P, Chen RT; Vaccine Adverse Event Reporting System Team. Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Am J Epidemiol. 2001;154:1006-1012.