This report is being filed after the subsequent review of the following journal article: lee, w.T., liu, g., thambiah, j., wong, h.K.(2015).Clinical outcomes of single level lumbar artificial disc replacement compared with transforaminal lumbar interbody fusion in an asian population.Singapore medical journal, p1-14.Singapore.This was a review of hospital records for synthes prodisc-l surgeries or transforaminal lumbar interbody fusion (tlif) between 2002 and 2007.The purpose of the study was to examine the clinical outcome of single level artificial disc replacement (adr) compared to tlif for the treatment of symptomatic degenerative disc disease (ddd) in asian population.The study population included: a total of 74 patients with 54 (41 males, 13 females) in adr group.Adr group ages ranged 21-55 years old with mean of 34.Surgery levels with adr group were l4/5 (n=21) and l5s1 (n=33).Follow up visits were at 2 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively.Only 38 were included in adr group with 2 year follow-up minimum.Surgical complications were not specified by surgery and therefore will be reported.Complications for prodisc-l: adr 3 ¿ pain free for 6 months, adjacent level pain and revised tlif at l5/s1 and l4/5 posterior decompression at implant level, pain free at last follow-up, facet joint osteoarthritis and scar tissue at l4/5 implant level.[mri].This is report #11 of 15 for (b)(4).This report is for an unknown prodisc-l with an unknown part number, lot number and quantity.
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Device was used for treatment, not diagnosis.Literature citation: lee, w.T., liu, g., thambiah, j., wong, h.K.(2015).Clinical outcomes of single level lumbar artificial disc replacement compared with transforaminal lumbar interbody fusion in an asian population.Singapore medical journal, p1-14.This report is for an unknown prodisc-l inferior endplate with unknown part and lot numbers.(b)(6).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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