It was reported in a publication that the authors retrospectively reviewed the charts of 57 consecutive pediatric patients who underwent posterior occipitocervical, cervical, thoracic, lumbar, or lumbosacral spine fusions with rhbmp-2 from october 1, 2007, to june 30, 2011.The surgery consisted of routine exposure of the spine over the entire length to be instrumented.Placement of segmental instrumentation, if performed, was done in standard fashion.Decortication of the laminae, spinous processes, and facet joints was performed using a matchstick bur after placement of spinal instrumentation.Increments of kits of rhbmp-2 were used in each case and applied on a collagen sponge.The collagen sponges were generally cut into 1-cm strips and placed in a single layer overlying the posterior elements after thorough decortication of the bone.The amount of rhbmp-2 was determined intraoperatively, depending on the surface area of the intended fusion levels.For the purposes of this study, patients and caretaker(s) were brought back to the clinic off schedule for assessment of the development of cancer, or were questioned via telephone follow-up by a clinical neurosurgery nurse.There were no new cases of cancer, or degeneration or metastasis of existing malignancies in this series.Case 31.Male, age 10 yrs, 6 months.The patient presented status post myelomeningocele with congenital kyphosis.The patient underwent kyphectomy and t9-ilium posterior instrumented fusion using local autograft and 20mg of bmp2.Post-op, the patient develop erosion of the instrumentation through the skin necessitating reoperation for removal, and delayed deep wound infection from soft tissue defect.
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Article citation: sayama et al.Routine use of recombinant human bone morphogenetic protein¿2 in posterior fusions of the pediatric spine and incidence of cancer.J neurosurg pediatr.2015 apr 10:1-10.Implant date: october 1, 2007 to june 30, 2011.(b)(6).(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.
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