A small portion of the unknown abutment zirconia was returned.The reported fracture was confirmed.The part and lot numbers were not provided; therefore, the risk management files could not be reviewed.A definite cause could not be determined.This event is being reported due to a single preceding medical device report where surgical intervention did occur.This event is a subsequent malfunction.The risk to the patient is remote.Investigation of other complaints with similar abutments that were fractured concluded the fracture was related to the design of the hex and boss connection and to the screw access hole which led to the recall.Date received by manufacturer, add follow up type, device evaluated by manufacturer: change ¿no¿ to ¿yes¿, add event problem codes, add evaluation codes.
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