Simplex P has proven through clinical testing to have high fatigue1, compressive2 and flexural strengths2, and low creep3.
Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
1.Davies JP, Jasty M, O'Connor DO, Burke DW, Harrigan TP, Harris WH. The effect of centrifuging bone cement. J Bone Joint Surg Br. 1989 Jan;71(1):39-42
2.Hansen D, Jensen JS. Mixing does not improve mechanical properties of all bone cements. Manual and centrifugation-vacuum mixing compared for 10 cement brands. Acta OrthopScand 1992; 63(1): 13-18
3.Holm NJ. The relaxation of some acrylic bone cements. Acta Orthop Scand. 1980 Oct;51(5):727-31.
1000-025-860 Rev None