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Device Problems
Break (1069); Unintended Movement (3026)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Patient information is unknown.Waldhausen j.H.T., redding g., white k., song k.(2016).Complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery.51: p.1747-1750.United states.Pma / 510k: this report is for an unknown veptr implant /unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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This report is being filed after the subsequent review of the following literature article waldhausen j.H.T., redding g., white k., song k.(2016).Complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery.51: p.1747-1750.United states.The purpose of this report was to describe complications using the vertical expandable prosthetic titanium rib (veptr) for thoracic insufficiency syndrome (tis) at a single center.The report reviewed 65 patients implanted with rib-rib and or rib-spine veptr devices.Patients with fractures created prior to the year 2008 were implanted with veptr i; while those who gained their fractures after the year of 2008 were implanted with veptr ii.It is unknown the year patients gained their fractures, making it unknown which patients were implanted with which veptr type (i or ii).Of the 65 patients, 12 had migration of either the superior cradle hook or the inferior fixation.Two (2) had migration of the sacral s hook into the pelvis.The other 9 had migration of the superior cradle.Nine (9) patients experienced wound infections.Two (2) of these 9 patients required implant removal as a result.Another 2 patients experienced skin breakdown/dehiscence.One (1) patient developed a postoperative radiculopathy that resolved over time.Three (3) patients had implant fracture, 1 from the veptr itself and 2 from the intramedullary wire placement.Two (2) patients experienced persistent pain, 1 from a broken intramedullary wire, 1 from the veptr rubbing on the native rib.Two (2) developed progressive scoliosis and needed fusion.One (1) developed pneumonia and another had a postoperative seroma.One patient died during follow up due to osteosarcoma because of his oncologic disease.According to the author of the article, no complications were due to the veptr.Any veptr that broke according to the author, is most probably attributed to a child being active and doing what they normally do.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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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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Search Alerts/Recalls
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