Device is not expected to be returned for manufacturer review/investigation.(b)(6).Patient code (b)(4) used for: the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Should further information become available this determination will be reviewed accordingly.Device history records review was conducted.The report indicates that the: manufacturing location: part 497.126 / lot 6881985 manufacturing location: (b)(4), manufacturing date: apr 30, 2012 no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
Device report from synthes on an event in (b)(6) as follows: it was reported that the patient suffers from progressive scoliosis with excessive thoracic deformity (primary disease: sotos syndrome).On (b)(6) 2012 the following two stabilizations were performed.A) hybrid type veptr (size 9) was applied, ranging from the right 2nd lib to the ileum.B) hybrid type veptr (size 7) was applied, ranging from the right 3rd lib to the 2nd lumbar spine.On (b)(6) 2012 the post-operative infection on the wounded are was confirmed.On (b)(6) 2012 a necessary treatment (unknown treatment details) was performed.The patient became well.On (b)(6) 2013, and (b)(6) 2014, the surgeries for adjusting veptr size was performed on respective dates.On (b)(6) 2014 the surgery for adjusting veptr size was performed.Superior mesenteric artery syndrome was noticed again (b)(6) 2014, however, the patient gradually became well.On (b)(6) 2014 it was reported that the patient has recovered.This complaint involves 16 parts.This report is 11 of 16 for (b)(4).
|