(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date of occurrence.Estimated date of implant.Unique device identifier (udi): the udi is unknown because the part number and lot number was not provided.There was no reported device malfunction, and the product was not returned.The reported patient effect of occlusion is a known potential patient effect as listed in the supera instructions for use.Although a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined, there is no indication the reported patient effect was caused by, or related to the design, manufacture or labeling of the device.A review of the lot history record could not be conducted because the lot number was not provided.
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