VEGA® RV IMPLANT Ø4.0 X 14MM

Additional Manufacturer Narrative

MECHANICAL FAILURE DUE TO IMPLANT FATIGUE CAUSED BY OVERLOAD, EXACERBATED BY CRESTAL BONE LOSS, IS ALSO EVIDENT. IT IS DIFFICULT TO SPECULATE ON THE CAUSE, AS NO INFORMATION IS AVAILABLE ON THE MORPHOLOGY OF THE RESTORED CROWN, ALTHOUGH IT CAN BE CONFIRMED THAT THE IMPLANT IS LOCATED IN AN AREA SUBJECT TO HIGH MECHANICAL STRESS. FRACTURE OF THIS TYPE OF DEVICE IS A POSSIBLE BUT UNLIKELY MECHANICAL COMPLICATION, WITH A RELATIVELY LOW INCIDENCE WHEN THE INSTRUCTIONS FOR USE ARE FOLLOWED (EQUAL OR LESS THAN 1% ACCORDING TO THE VALUES REPORTED IN THE CLINICAL EVALUATION OF KLOCKNER® DEVICES). HOWEVER, THE COMBINATION OF ALL THE FACTORS MENTIONED IN THE TECHNICAL CAUSES INCREASES THE PROBABILITY OF ITS OCCURRENCE.

Description of Event or Problem

THE CUSTOMER REPORTS THE BREAKAGE OF A VEGA RV IMPLANT IN A PATIENT. THEY PROVIDE THE CORRESPONDING QUALITY REPORT AND X-RAYS OF THE IMPLANT PLACED WITHOUT THE PROSTHESES.