ADVANSYNC

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 2011-12-22 for ADVANSYNC manufactured by Ormco Corporation.

Event Text Entries

[2401140] On (b)(6) 2011, a doctor alleged that a patient developed a cheek ulceration from wearing the advansync appliance. A fever and general malaise was also noted. On (b)(6) 2011, it was reported that the patient sought medical attention with her family physician and was prescribed antibiotics.
Patient Sequence No: 1, Text Type: D, B5


[9448734] Treatment also included mouth rinses. To date, the patient has fully recovered and is doing fine. A new appliance with not be placed and re-fabrication of the original appliance will not be implemented because the patient has completed the course of treatment.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2011-00212
MDR Report Key2386895
Report Source05
Date Received2011-12-22
Date of Report2011-12-13
Date Mfgr Received2011-11-23
Date Added to Maude2011-12-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. ORLANDO TADEO, JR.
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167419
Manufacturer G1ORMCO CORPORATION
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANSYNC
Generic NameBITE-JUMPING ORTHODONTIC APPLIANCE
Product CodeEJF
Date Received2011-12-22
ID NumberWORK ORDER #3361874
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2011-12-22

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