VEGA NV Ø3.5 X 10MM IMPLANT

Additional Manufacturer Narrative

IN THE CASE OF IMPLANT 18 35 10: MECHANICAL FAILURE DUE TO IMPLANT FATIGUE CAUSED BY OVERLOAD IS EVIDENT, EXACERBATED BY: PROGRESSIVE CRESTAL BONE LOSS, LEADING TO REDUCED IMPLANT SUPPORT FOR TRANSMITTING CHEWING FORCES FROM THE TOOTH TO THE BONE. THE MORPHOLOGY OF THE CROWN INCREASES THE "LEVER" EFFECT ON THE DENTAL IMPLANT DUE TO THE RELATIONSHIP BETWEEN THE DIAMETER OF THE IMPLANT (3.5 MM) AND THE MESIODISTAL SIZE OF THE CROWN (9.5 MM). CONCENTRATION OF STRESSES AT THE CRESTAL JUNCTION DUE TO BONE LOSS, WHERE THE IMPLANT ULTIMATELY FRACTURES DUE TO THE CYCLIC LOADS OF MASTICATORY FUNCTION.

Description of Event or Problem

THE CUSTOMER REPORTS THE BREAKAGE OF ONE VEGA IMPLANT (NV) IN A PATIENT. HE PROVIDES THE CORRESPONDING QUALITY REPORTS AND X-RAYS OF THE IMPLANT PLACED WITHOUT THE PROSTHESE.