While no serious injury resulted in this event, there has been a previous report received with a similar device 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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Returned start-x tip ems insert 3 is actually broken in the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for possible evaluation.The batch number is unknown, dhr cannot be reviewed.No information was given regarding technique, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.
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