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.Involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1536535).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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