FDA.reportPublic FDA data

MAUDE MDR 6786844

MDR report key
6786844
Report number
3005174370-2017-00044
Event key
0
Event type
3
Date received
2017-08-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANGIE DRAPER
Address
2510 CONWAY AVENUE ST. PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13M ESPE STAINLESS STEEL PRIMARY MOLAR CROWNCROWN, PREFORMED3M ESPE DENTAL PRODUCTSELZND-96R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-1001. R

Event Narratives#

N

Patient 1

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 FIRST PRODUCT. MANUFACTURER REPORT 3005174370-2017-00045 REPRESENTS THE SECOND PRODUCT.

D

Patient 1

ON (B)(6) 2017, 3M WAS NOTIFIED THAT AN (B)(6) 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.