Device has not been reported as explanted.(b)(4).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.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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Product investigation summary: the complainant part was not explanted from the patient; therefore, a full investigation into the reported issue could not be conducted.However, a review of the design drawings was completed.Additionally, the case was further discussed with the surgeon who had performed the procedure.The surgeon placed the graft over the exposed brain as an on-lay.Then the corners of the synthecel were laid over the bone at the margin, which allowed the surgeon to find the layer of synthecel more easily.Following that step, the surgeon began dissection of the synthecel form the skin flap.After four (4) months, when the surgeon lifted up the scalp, a nice plane between the scalp and the dura was discovered.The surgeon was able to very easily lift up the scalp with a bit of dissection as there was some adherence between the synthecel and scalp.The majority of the piece of synthecel was stuck on to the underlying dura and the brain; none of which lifted up.Device 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.Evaluation conducted w/out device.
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