This report is being filed after the subsequent review of the following journal article: waldhausen, j.H.T., redding, g.J., and song, k.M.(2007).Vertical expandable prosthetic titanium rib for thoracic insufficiency syndrome ¿ a new method to treat an old problem.Journal of pediatric surgery vol 42, p76-80.Usa article.This was retrospective review of performed between (b)(6) 2001 and (b)(6) 2005.The study population included: 22 patients, 36 veptr devices, most had undergone sequential veptr expansions, age range 1 year and 8 months ¿ 15 years and 3 months.Twenty seven devices were hybrid and 9 were radial constructs.Patients had between 1-3 veptr devices placed.Complications included: veptr erosion through bone or dislodgment (n=7) which required revision surgery (most at the superior grade of hybrid device; 3 patients had implants removed.Outgrown (n=5) and were replaced or removed.Soft tissue erosion/eschar (n=1) causing superficial infection that was debrided and resolved with a revision.Carbon dioxide reduction post-veptr (n=2), post-op seroma (n=1), average age 8.38 years had worse ventilation on the affected side, avg age 6.64 years had worse perfusion post-op, worse respiratory function (n=2) needing increased respiratory support and progression to non-invasive ventilation.(b)(4) 2015, update: k-wires utilized during veptr surgery as intramedullary pins which were placed into ribs to recreate the horizontal portion of the rib and tie it to the veptr.Surgeon stated, "wires tended to break over time due to stress." k-wires part of veptr set per surgeon.This report for k-wires breaking due to stress.This is report 3 of 4 for (b)(4).This report is for an unknown veptr with an unknown part number, lot number and quantity.
|
Device was used for treatment, not diagnosis.(b)(4).This report is for an unknown veptr k-wire with unknown part and lot numbers.(b)(6).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.
|