FDA.reportPublic FDA data

MAUDE MDR 6599788

MDR report key
6599788
Report number
2081322-2017-00002
Event key
0
Event type
3
Date of event
2017-05-01
Date received
2017-05-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARY PEARMAN
Address
1822 ASTON AVENUE CARLSBAD CA 92008 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARRIERE MOTION CLASS IIBRACKET, METAL, ORTHODONTICORTHO ORGANIZERS, INC.EJF424-925CNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-3001. R

Event Narratives#

N

Patient 1

THE ORTHODONTIST REMOVED AS MUCH COMPOSITE AS POSSIBLE AROUND UL3, UL6, UR4 AND UR6. ONCE THE EXCESS COMPOSITE WAS REMOVED, THE DENTAL ASSISTANT USED A BRACKET REMOVING PLIER AND SQUEEZED BETWEEN THE BONDING PAD AND TOOTH. A 1MM OF INCISAL ENAMEL UL3 WAS FRACTURED. A SMALL AMOUNT OF FLOWABLE COMPOSITE RESIN WAS BONDED TO THE ENAMEL FRACTURE. BECAUSE THE APPLIANCE WAS BONDED TO THE VERY INCISAL EDGE OF THE FACIAL SURFACE, THE ORTHODONTIST THOUGHT THE ENAMEL MAY HAVE BEEN TOO BRITTLE AT THE EDGE OF THE TOOTH. ADDITIONALLY, THE ORTHODONTIST SWITCHED THE BONDING AGENTS APPROXIMATELY 9 MONTHS AGO DUE TO EXCESSIVE BOND STRENGTHS HE WAS EXPERIENCING, WHICH MAY HAVE LED TO THE FRACTURED ENAMEL. DEVICE NOT RETURNED.

D

Patient 1

TOOTH FRACTURE WHILE DEBONDING CARRIERE MOTION APPLIANCE WHEN REMOVING THE CARRIERE FROM #11 TOOTH, THE MESIAL EDGE OF THE TOOTH FRACTURED OFF WITH THE CARRIERE. THE PATIENT IS SYMPTOM FREE.