510 k: this report is for an unknown screw/rod construct accessories/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.No conclusion could be drawn at the time of filing this report.(b)(4).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.
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Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article, linhardt o., grifka j., benditz a., (2015), ' are there segmental differences of lumbar spondylodesis? - comparison of the segments l iv/v and l v/s i in patients with transforaminal lumbar intracorporal fusion (tlif), zeitschrift für orthopädie und unfallchirurgie'.Volume 153, pages 546-551(germany) doi: 10.1055/s-0035-1557908.This prospective study aims to present the operative results of open tlif spondylodesis of segment l v/s i in comparison to segment l iv/v, considering its special anatomical conditions.Between 1/2011 and 1/2014,a total of 60 patients were operated on for degenerative spinal disease with corresponding symptoms using spondylodesis in open tlif technique were enrolled in the study.30 patients each were operated on monosegmentally in segment l iv/v (group 1) and l v/s i (group 2).30 patients (18 females, 12 males) with mean age of 54 years (32-79) in segment l iv/v (group 1) and 30 patients (20 females, 10 males) with mean age of 51 years (16-81) in segment l v/s i (group 2) were treated with tlif.All patients underwent distraction spondylodesis.The primary procedure was the insertion of the internal fixator (expedium system from depuy).Insertion of devex cage from depuy was also done.Patients were followed up 2 weeks and 12 months after surgery.The following complications were reported as follows: -ne patient in group 1 had to undergo revision surgery 2 days postoperatively due to a screw malposition.One patient in group 1 showed delayed wound healing, which healed without revision with antibiotic treatment.One patient in group 1 developed a pronounced degeneration in the underlying segment with severe pain symptoms 6 months postoperatively, necessitating a second operation with spondylodesis extending over two segments.Two weeks postoperatively, all patients were still taking nsaids because of wound pain.In addition, 3 patients in group 2 still needed opiates regularly because of severe painful dysesthesia.One year postoperatively, 7 patients in group 1 and 5 patients in group 2 occasionally took nsaids for mild back pain.This may be explained by reversible dysesthesias in 3 patients in group 2.Two patients from group 2 underwent dorsoventral spondylodesis using the alif technique, as an originally planned tlif was not possible due to highly contracted conditions.This procedure was not considered a complication.This report is for an unknown depuy spine expedium system and unknown depuy spine devex cage.A copy of the literature article is being submitted with this medwatch.This report is for (1) unknown screw/rod construct accessories.This is report 2 of 3 for (b)(4).
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