(b)(4).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.
|
During cement injection the cement pump built pressure until the upper gasket was broken and leaked.Was surgery delayed due to the reported event? no.Action taken when event occurred? replacing the cement pump to a new one.Was procedure successfully completed? yes.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.Is the patient part of a clinical study: unknown.Ip (b)(4).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves two (2) devices.
|