ULTRACAL XS

Additional Manufacturer Narrative

IT HAS BEEN WIDELY KNOWN SINCE AT LEAST 1920 THAT CALCIUM HYDROXIDE HAS GREAT HEALING POWERS IN THE TOOTH DUE TO ITS HIGH PH, WHICH KILLS MICROORGANISMS IN TEETH AND ITS BIOACTIVITY TO REGENERATE TOOTH AT THE APEX. IN THIS CASE, BASED ON THE INFORMATION RECEIVED THUS FAR IN THE LITIGATION, THE GROSS OVER EXTRUSION OF ULTRACAL (CALCIUM HYDROXIDE) PAST THE APICAL FORAMEN IN A LOWER FIRST MOLAR RESULTED IN ALLEGED LONG-TERM PAIN, PARESTHESIA, AND EVENTUAL EXTRACTION OF THE INVOLVED TOOTH. HAVING THIS ALLEGED SEQUELAE HAPPEN AS A RESULT OF ROOT CANAL TREATMENT CAN HAPPEN, BUT IT IS DEFINITELY NOT THE STANDARD OF CARE IN ENDODONTICS TO HAVE THIS HAPPEN. IT HAS BEEN WELL KNOWN FOR ALL THESE YEARS. DENTISTS RECEIVE TRAINING IN DENTAL SCHOOL AND ANNUAL CONTINUING EDUCATION TRAINING THAT AN EXTRUSION (MISUSE) OF THIS CHEMICAL OUTSIDE THE CONFINES OF THE TOOTH MAY CAUSE THE PATIENT TO HAVE ISSUES SIMILAR TO THOSE ALLEGED TO HAVE OCCURRED HERE.

Description of Event or Problem

PATIENT CLAIMS "BURNING AND NUMBNESS IN HIS LOWER LEFT FACE."