Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the primary surgery for the patient took place on (b)(6) in 2009 due to congenital scoliosis.On (b)(6) in 2013, the patient underwent surgery for revision with the veptr system.On (b)(6) 2014, during the routine checkup for the patient, the surgeon found the breakage of the veptr on the x-ray image.The underlying cause of the breakage is still unknown.The patient was admitted to the hospital on (b)(6) 2014 and underwent the third surgery in order to remove the veptr on (b)(6) 2014 (between the left 6th rib and the 3rd lumbar vertebrae).The patient was in a good condition as of (b)(6) 2014 after the surgery.This report is 1 of 1 for (b)(4).
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Device was used for treatment, not diagnosis.This report is for one unknown partveptr/unknown lot number.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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