A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.It was reported that the patient had poor bone quality and that the surgeon was not concerned about the integrity of the overall construct.Since the implants remain in the patient and the screw was disposed, no examination could be completed and therefore a definitive root cause could not be determined.(related to 3004774118-2017-00052 and 3004774118-2017-00058).In situ/disposed.
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