Current information is insufficient to permit a conclusion as to the cause of the event.Evaluation of software found no evidence of product non-conformance.Digital implant image comparison testing was conducted and all images were accurate.Analysis of patient x-rays found the incorrect protocol was used, resulting in the incorrect template sizes.There are warnings in the package insert that state that this type of event can occur: "a trained medical professional determines final implant type and size intraoperatively." "orthosize software does not determine the final size and type of hardware to be implanted.".
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