Once notified via e-mail it was noted the cover had broken free from the radial plate and the plate itself was extremely dorsally angulated.Contact with the surgeon was made on (b)(6) 2021 to gather further information.The surgeon stated the patient felt the prosthesis break as she was using her arms to lift herself out of a chair.The surgeon stated that he did not follow the technical guidance and positioned the plate dorsally angulated due to the shape of the radius.He also acknowledged that all guidance requires the plate to be properly positioned but he felt the altered positioning would be acceptable.The device failed due to the mal-positioning which altered the forces passing through the device to an extreme.
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