(b)(4), unknown.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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During inserting verse set screw 199721001 with bully the set screw cross threaded and set screw was damaged (threads were deformed and parts fell off) was surgery delayed due to the reported event? yes, if yes, number of minutes: 5, was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.This complaint involves one (1) device.
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