There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.We compared the build model with the plaster model.There is a deviation at the teeth 17 and 28 which probably causes the non fit in the patient mouth.The model in planning wasn't the same as situation in the patient's mouth.
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