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Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Date of event: 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.Other number: udi: unknown part number, udi is unavailable.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.Patient 2, female, date of birth: (b)(6), congenital scoliosis, migration of the laminar hook caudally during the veptr distraction period, spondylodesis had to be extended from t1 to l5 this is report 2 of 5 for (b)(4).This report is for an unknown veptr system.
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Search Alerts/Recalls
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