Mdr 2183456-2020-00017 has been filed past the 30-day timeframe.Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur.As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.While the out of specification condition associated with this report was identified by the surgeon prior to use, recurrence of this issue could potentially impact patient safety if the burr were to make patient contact and remain in situ following the intended surgical operation.
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