TRANSCEND UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-03-19 for TRANSCEND UNK manufactured by 3m Unitek.

Event Text Entries

[49250] Orthodontist stated that while debonding ceramic brackets, teeth fractured (tooth #23 and tooth #27). Follow-up therapy will include crowns, and root canals if required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020467-1997-00003
MDR Report Key78282
Report Source05
Date Received1997-03-19
Date of Report1997-03-18
Date of Event1994-03-14
Date Mfgr Received1997-03-18
Date Added to Maude1997-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSCEND
Generic NameORTHODONTIC CERAMIC BRACKET
Product CodeDYW
Date Received1997-03-19
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key77911
Manufacturer3M UNITEK
Manufacturer Address2724 SOUTH PECK RD MONROVIA CA 91016 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.