Concomitant medical products: dpsc screw, 21mm; catalog#: 01.04440.021; lot#: 2995206.Dpsc screw, 36mm; catalog#: 01.04440.036; lot#: 2994818.Therapy date: unknown.The manufacturer received other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
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