VEGA RV Ø4.5 X 08MM / VEGA RV Ø4.0 X 08 MM IMPLANT

Description of Event or Problem

A DISTRIBUTOR (KLOCKNER OF NORTH AMERICA) INFORMS SOADCO, S.L. THAT A DOCTOR COMMENTS THAT: -THE PATIENT PRESENTED SEVERE PERI-IMPLANTITIS 3 WEEKS AFTER THE SURGICAL OPERATION AND A MODERATE RESORPTION OF THE ALVEOLAR CREST IS OBSERVED, WITH BONE TYPE I-II. THE USER SPECIFIES IN THE QUALITY REPORT SEND TO THE MANUFACTURER (SOADCO, S.L.) THAT THE FAILURE IS DUE TO SOME PATIENT'S UNKNOWN FACTORS.

Additional Manufacturer Narrative

SOADCO, S.L. REQUESTED MORE INFORMATION TO ANALYZE THE INCIDENT, BUT THE CLIENT DID NOT SEND THE AFFECTED DEVICES OR ANY FOLLOW-UP X RAYS FROM THE TIME THE IMPLANTS WERE PLACED OR FROM MOMENTS PRIOR TO EXTRACTION. BASED ON THE AVAILABLE INFORMATION, IT CAN BE STATED THAT THE INCIDENCE IS MORE RELATED TO THE PAOTIENT'S ORAL HEALTH THAN TO AN INCIDENCE OF THE PRODUCT TO AN INCIDENCE OF THE PRODUCT. IT IS OBSERVED THAT THE PATIENT IS A SMOKER, A HABIT CONTRAINDICATED.