510k: this report is for an unknown screw/rod construct accessories /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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 the review of the following journal article: tsagozis, p.And bauer, h.C.F.(2019), outcome of surgical treatment for spinal cord compression in patients with hematological malignancy, international journal of spine surgery, vol.13, no.2, pages 186¿191 (sweden).The objective of this study is to review prospectively collected data of 50 consecutive patients surgically treated for mscc due to lymphoma or myeloma between july 1993 and december 2012, and we documented the treatment outcomes.Between july 1993 and december 2012, a total of 50 patients (19 females and 31 males) with a median age of 65 years (range, 31¿85 years) were included in the study.Instrumentation was used in 29 patients, whereas 21 patients underwent posterior decompression only.The implants used for posterior fixation were the universal spine system in 17 patients, the cotrel-dubousset in 5 patients and the isola system in 5 patients, respectively.Anterior decompression and stabilization with a z-plate were performed in 1 patient and with the telefix system in another.The mean follow-up was 45 months.The article did not specify which of the devices were being used to capture the following complications: at last follow-up, 7 patients were still alive.The early postoperative mortality rate was 8 percent, given that there were 4 deaths due to cardiovascular compromise and failure in the first 30 days after the operation.Ambulatory capacity was restored in 19 of 26 patients who were unable to walk preoperatively.In the case of minor neurological deficits on presentation, 3 deteriorated.Of the 2 totally paretic patients, neither became ambulatory but 1 improved to frankel c.5 patients had wound infection and dehiscence.2 of these presented with late chronic infections requiring extraction of the implants combined with antibiotic treatment until healing.2 patients needed wound debridement and flap reconstruction for the healing of the infection.3 patients had postoperative hematoma formation, 2 of which were surgically evacuated.2 patients had iatrogenic nerve or dura injuries.1 patient had sepsis and ileus.1 patient had a secondary operation due to the recurrence of neurological symptoms.This is report 1 of 1 for (b)(4).This report is for an isola system.
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