3M ESPE RELYX LUTING PLUS CEMENT

Additional Manufacturer Narrative

UPON 3M FOLLOW-UP WITH THE PATIENT'S PEDIATRIC DENTIST WHO PLACED THE STAINLESS STEEL CROWN, A PERFORATION OF A STAINLESS STEEL CROWN IS NOT UNUSUAL, ESPECIALLY AFTER ALMOST THREE YEARS, AND COULD BE CAUSED BY THE MASTICATORY FUNCTION OF THE CHILD OR BRUXISM. HOWEVER, IT SHOULD BE NOTED THAT 3M HAS NOT RECEIVED ANY SIMILAR COMPLAINTS OF THIS NATURE IN THE PAST. THIS EVENT INVOLVED TWO 3M PRODUCTS; THEREFORE, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT REPRESENTS THE SECOND PRODUCT. MANUFACTURER REPORT 3005174370-2017-00044 REPRESENTS THE SECOND PRODUCT.

Description of Event or Problem

ON (B)(6) 2017, 3M WAS NOTIFIED THAT AN (B)(6) YEAR-OLD MALE PATIENT REQUIRED A TOOTH EXTRACTION DUE TO TOOTH DECAY WHICH WAS NOTED AFTER A 3M STAINLESS STEEL CROWN FELL OFF HIS TOOTH. THE STAINLESS STEEL CROWN WAS REPORTED TO HAVE A HOLE IN THE CENTER SURFACE. THE CROWN WAS ORIGINALLY PLACED IN (B)(6)2014 USING 3M ESPE RELYX LUTING PLUS CEMENT.