This report is being filed after the subsequent review of the following journal article: "scoliosis research society 47th annual meeting and course final program.Abstract# 30: joshua m.Pahys et al: comparison of surgical treatments for infantile and juvenile scoliosis." a retrospective review of 31 patients evaluated vertical expandable prosthetic titanium rib (veptr) vs.Growing rods (gr) for the treatment of infantile/juvenile scoliosis.Eighteen (18) patients of the 31 were treated with the vertical expandable prosthetic titanium rib and the rest of the 13 patients were treated with growing rods.There was no difference between the two groups (age at initial surgery, sex, diagnosis, height/weight, and preop coronal/ sagittal cobb angle).Average follow-up for vertical expandable prosthetic titanium rib was 4.2 years vs growing rods 3.5 years.Among the 18 patients that were treated with vertical expandable prosthetic titanium rib; complications occured in 8, instrument migration/failure in 12 patients and wound infection in 5 patients.This is report 1 of 4 for (b)(4).This report is for unknown veptr, implanted in 12 patients.
|
Device was used for treatment, not diagnosis.Date the abstract was published is unknown.This report is for unknown veptr, unknown part/unknown lot.This report for 12 unknown veptr.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Joshua et al, comparison of surgical treatments for infantile and juvenile scoliosis, pg# 72 abstract# 30 scoliosis research society, 47th annual meeting & course, sep 5-8, 2012.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|