Identifying information of the part, such as the part number and lot number of the device was not reported to paragon 28.The implantation date was said to have been in (b)(6) 2017 and the implant was not removed.Radiographic review shows that the most distal of the two proximal screws was too close to the joint therefore created more stress to the joint.The device history record was reviewed and met all material specifications with no deviation identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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