FDA.reportPublic FDA data

MAUDE MDR 7054445

MDR report key
7054445
Report number
2020467-2017-00003
Event key
0
Event type
3
Date of event
2017-09-27
Date received
2017-11-22
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
1APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBEADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN3M UNITEK CORPORAIONDYH4069-5114R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-2201. R

Event Narratives#

N

Patient 1

SINCE TWO 3M UNITEK PRODUCTS WERE INVOLVED IN THIS EVENT, TWO MANUFACTURER REPORTS ARE BEING FILED. THE CURRENT MANUFACTURER REPORT IS RELATED TO THE FIRST DEVICE AND MANUFACTURER REPORT 2020467-2017-00004 IS RELATED TO THE SECOND DEVICE.

D

Patient 1

ON (B)(6) 2017, 3M WAS NOTIFIED BY AN ORTHODONTIST THAT THE TOP LAYER OF ENAMEL BROKE OFF A (B)(6) MALE PATIENT'S TOOTH (#3) UPON DEBONDING OF A 3M UNITEK APC FLASH FREE VICTORY SERIES FIT BUCCAL TUBE. 3M UNITEK TRANSBOND PLUS SELF-ETCHING PRIMER WAS USED TO PLACE THE BRACKET. THE ORTHODONTIST SENT THE PATIENT TO THEIR DENTIST TO HAVE THE TOOTH REPAIRED. UPON FOLLOW-UP BY 3M WITH THE ORTHODONTIST, IT WAS LEARNED THAT THE ENAMEL DAMAGE WAS DOWN TO DENTIN AND THE ORTHODONTIST REPORTED THAT THE TOOTH APPEARED TO BE NORMAL PRIOR TO THIS EVENT.