It was reported that there was an issue with the product 1067050 - lyoplant onlay 10.0x12.5cm.According to the complaint description, the product caused a leakage of an unknown, clear liquid.It was noted on the top side of the skull, around the parietal bone area, postoperatively after 1-2 months when putting skull flap back.They ensured the overlap of 1 centimeter for the cases; and proceed with correct side with onlay application not underlay.A revision surgery was not necessary, the physician monitored the patient's status.No infection occurred.The malfunction is filed under aag reference (b)(4).
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