It was reported that there was an issue with ff492t-craniofix 2 titanium clamp 20mm.According to the complaint description, the surgeon used craniofix to fix his bone flap.He tightened it to hold it in place but when he cut the stem, the top of the craniofix jumped off.This event/malfunction prolonged the surgery for 20 minutes.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).
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Additional information - b5, d4 (udi), e1.Corrected information - b1, b2, d9, h1.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.The provided implant is in original sealed blister.The defect / complained product is not available for analysis.
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Additional information was received which revealed that "the surgeon used craniofix to fix his bone flap.He tightened it to hold it in place, but when he cut the stem, the top of the craniofix jumped off." subsequently, the physician had to use "more craniofix." an additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).
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