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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Lattig, f., et al.(2016) treatment of early-onset spinal deformity (eosd) with veptr.Clin spine surg; 29:e246-e251.This report is for unknown veptr, unknown quantity, unknown lot.(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.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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Event Description
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Literature article received: this report is being filed after the subsequent review of the following literature article: lattig, f., et al.(2016) treatment of early-onset spinal deformity (eosd) with veptr.Clin spine surg; 29:e246-e251.X-rays of 5 children treated for early-onset spinal deformity (eosd) with 2 unilateral vertical expandable prosthetic titanium rib (veptr) were analyzed for curve patterns and cobb angles before, during, and at the end of veptr treatment, and after the final spondylodesis.All patients showed a marked decompensation of the frontal balance.Five patients were included in the study.This report is for an unknown veptr system.Patient 3, female, date of birth: (b)(6), neurofibromatosis, veptr implantation was unable to slow down curve progression and seemed to worsen the trunk imbalance of the patient because of the distraction direction of the veptr system this is report 3 of 5 for (b)(4).
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Search Alerts/Recalls
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