SNAPLINK BUCCAL TUBE

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 2013-08-14 for SNAPLINK BUCCAL TUBE manufactured by Ormco Corporation.

Event Text Entries

[3823017] A doctor alleged that approximately twenty (20) patients had experienced the rotation of a lower first molar after the doors of the snaplink buccal tubes had broken. This is the second of twenty (20) reports.
Patient Sequence No: 1, Text Type: D, B5


[11004938] Patient specifics with regard to gender, age, and weight were not provided by the doctor. Although the doctor identified two different snaplink catalog numbers associated with the rotation of the patient's molar, he could not verify which catalog number was used on the patient; therefore, no catalog numbers were identified this report. The catalog numbers involved in the alleged incident include 438-2191 and 438-2190. The doctor replaced the patient's buccal tube, without further incident. To date, the patient is doing fine. The device involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2013-00078
MDR Report Key3287318
Report Source05
Date Received2013-08-14
Date of Report2013-08-06
Date Mfgr Received2013-08-06
Date Added to Maude2013-08-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
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 NameSNAPLINK BUCCAL TUBE
Generic NameORTHODONTIC TUBE
Product CodeDZD
Date Received2013-08-14
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILLS AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2013-08-14

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