This report is for an unk - constructs: veptr/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.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 synthes reports an event in poland as follows: this report is being filed after the review of the following journal article: danielewicz a., et al (2020) comparison of different surgical systems for treatment of early onset scoliosis in the context of release of titanium ions, spine an international journal for the study of the spine volume xxxxx, pages 1-15 (poland) doi: 10.1097/brs.0000000000003846.This study aims to compare these systems : tgr, ggs and veptr in the context of titanium release.In 2015-2016 ,a total of 71 patients (53 girls and 18 boys) with average age of 13.5±3.54 years and the average time of treatment was 2 ±2.8 years who were treated for spinal deformity were included in the study.The patients were divided into four groups of patients treated with the traditional growing rod (tgr) with 38 patients (8 males, 30 females) age 13.5 ± 3.8 years, guided growth system (ggs) with 10 patients (0 males,10 females) age 13.4 ± 1.6 years and vertical expandable prosthetic titanium rib (veptr) with 9 patients (4 males, 5 females) age 12.3 ± 1.6 years.The fourth group comprised of 14 patients (6 males, 8 females) age 12.6 ± 2.7 years who required a revision procedure because of rod breakage.The following complications were reported: metallic staining of paraspinal tissue was observed in the case of the ggs and veptr systems.An increased level of titanium compared with the control was noted in all the groups of patients.In the case of veptr, metallosis was visible along the entire length of the stabilization.The fourth group comprised of 14 patients who required a revision procedure because of rod breakage.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This report is for (1) unk - constructs: veptr.This is report 1 of 2 (b)(4).
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