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There are multiple patients.All known information is provided in the journal article.This report is for an unknown veptr construct/unknown lot.Part and lot number 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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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This report is being filed after the review of the following journal article: campbell, r.M.(2011), operative strategies for thoracic insufficiency syndrome by vertical expandable prosthetic titanium rib expansion thoracoplasty, operative techniques in orthopaedics, vol.15 (no.4), pages 315-325 (usa).The aim of this study is to evaluate the operative techniques for thoracic insufficiency syndrome using veptr expansion thoracoplasty.A total of 27 patients with the mean age at the time of surgery was 3.2 years.Surgery was performed using synthes longitudinal rib retractor and vertical expandable prosthetic titanium rib (veptr).The mean duration of follow-up is 5.7 years.The following complications were reported: 2 patients died; one due to postoperative bacterial pneumonia acutely and the second 2 years after surgery following the development of respiratory failure with later pneumonia unrelated to surgery.A (b)(6)-old boy with congenital scoliosis and fused ribs had dural leak and monoplegia.At 5-year follow-up, there has been an almost complete resolution of the monoplegia, correction of scoliosis, and growth of the thoracic spine and rib cage.He is ambulatory without restrictions, runs and plays with his peers, and has a vital capacity of 54% normal.In 21 patients, their spinal growth was found that the concave side of the spine of these curves with extensive involvement of unilateral unsegmented bars grew at an average rate of 7 percent a year with a similar significant increase in the length of the bars.Mean estimated blood loss at the initial surgery was 57 ml.One-half of patients required a blood transfusion during the first 2 postoperative days.All patients were felt to be at risk of developing respiratory insufficiency.3 patients had oxygen support.1 of these was weaned off continuous positive airway pressure oxygen support and went on to normal activities and was breathing room air.2 patients on room air preoperatively went on to require respiratory assistance years after surgery, one requiring continuous positive airway pressure and the other requiring nighttime nasal oxygen.Thoracic kyphosis preoperatively was a mean of 14 degrees preoperatively and increased to a mean of 33 degrees at follow-up.1 of the 4 patients with myelomeningocele had clinical signs of secondary thoracic insufficiency with positive marionette sign and this resolved following treatment.7 patients had skin slough.4 of these were treated with debridement and primary closure with one requiring temporary removal of the device and later re-insertion.While 3 others are associated with infection and were treated with debridement and intravenous antibiotics.6 patients developed a latex allergy.2 patients had upper-extremity brachial plexopathy on the operative side after surgery and responded to later repositioning of the devices.1 patient had spinal cord injury, a brown-sequard syndrome with monoparesis, developed after resection of a thick mass of fused ribs with violation of the spinal canal and dural leak.This went on to almost complete resolution at 2.8 years after surgery.The mean forced vital capacity at the time of the last follow-up, at the mean of 5.9 years after surgery, was 49% predicted normal value.Those patients younger than age 2 years at time of surgery, at an age when lung growth is best due to alveolar cell multiplication, had a mean vital capacity of 58%, whereas those patients aged 2 or older at time of initial surgery had a mean vital capacity of 44%, but those patients aged 2 years or older with a history of spinal fusion in infancy had a mean vital capacity of only 36%.Scoliosis decreased from a mean of 74 degrees preoperatively to a mean of 49 degrees at the time of the last follow-up.4 patients had a spinal hook migration posterior-inferiorly with complete disengagement at a mean of 2 years.All were reseated through limited incisions.7 patients had a slow asymmetric migration of the superior cradle of the hybrid device through the proximal ribs of attachment with complete migration over a mean of 3 years.All were discovered fortuitously on preoperative x-rays for scheduled expansion procedures and these superior rib cradles were easily reseated through 4-cm incisions.This report is for an unknown synthes veptr construct.This is report 2 of 5 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.(b)(4).
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