Garcia, r., et al (2015).Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activl multicenter randomized controlled ide clinical trial.Spine.40(24), pp 1873-1881.This report is for an unknown pro-disc l inferior endplate/unknown lot/quantity unknown.(b)(4).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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This report is being filed after subsequent review of the following journal article garcia, r., et al (2015).Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the activl multicenter randomized controlled ide clinical trial.Spine.40(24), pp 1873-1881.The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (tdr) in the treatment of patients with symptomatic degenerative disc disease (ddd) who are unresponsive to nonsurgical therapy.Patients presenting with symptomatic single-level lumbar ddd who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational tdr device (activl, n=218) or fda-approved control tdr devices (synthes prodisc-l or charite, n=106).A total of 324 patients (218 activl, 106 control) were randomized at 14 sites between january 2007 and december 2009.Of the 106 controls, 64 received the prodisc-l.Two cases of subsidence and 1 case of device migration were identified through 2 years, all in the control group.Device disassembly was noted in one activl patient and two controls.Heterotopic ossification interfering with range of motion was identified in 1.6% and 1.1% of patients treated with activl and control, respectively.The most commonly reported device-related serious adverse events (aes) were lumbar/leg pain and implant subsidence.Implant expulsion occurred in 0.9% of patients in the control group.The percentage of patients undergoing surgical reintervention at the index level was comparable between groups through 2 years.The reasons for reintervention were ongoing pain, device malposition, and lumbar spinal stenosis (activl group).This report is for an unknown pro-disc l inferior endplate and surgical reintervention due to device malposition.This is report 6 of 9 for complaint (b)(4).
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