Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the initial surgery on (b)(6) 2010, the cradle type veptr (vertical expandable prosthetic titanium rib) was set for the sixth through the tenth right rib and the hybrid veptr was set for the right forth rib through the forth lumbar vertebrae.On (b)(6) 2014, kyphosis at the junction was determined, as the patient was taking a wait and see approach.It was also reported that on (b)(6) 2014 during a preoperative examination; it was determined that the kyphosis worsened.At this time, the removal of veptr was decided due to the uncontrolled expansion of the veptr system.On (b)(6) 2014, the entire veptr system was extracted and the growing rod was replaced.There was no report of implanted parts being left inside of the patient or a report of any surgical delay.This report is for an unknown veptr.This report is 1 of 1 complaint (b)(4).
|