INSPIRE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-03-15 for INSPIRE UNK manufactured by Ormco Corp..

Event Text Entries

[253257] The orthodontist stated that while debonding the inspire bracket with debonding pliers, the facial cusp of the upper right 1st bicuspid broke away from the rest of the tooth. The orthodontist grinded the rest of the brackets off the remaining teeth. The orthodontist immediately referred the patient to their general dentist who applied a porcelain crown to the damaged tooth.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2016150-2002-00001
• MDR Report Key: 382559
• Report Source: 05,07
• Date Received: 2002-03-15
• Date of Report: 2002-02-26
• Date of Event: 2002-02-26
• Date Mfgr Received: 2002-02-26
• Date Added to Maude: 2002-03-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: WENDY URTEL
• Manufacturer Street: 1717 WEST COLLINS AVENUE
• Manufacturer City: ORANGE CA 92867
• Manufacturer Country: US
• Manufacturer Postal: 92867
• Manufacturer Phone: 7145167425
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INSPIRE
• Generic Name: ORTHODONTIC BRACKET
• Product Code: DYW
• Date Received: 2002-03-15
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 371633
• Manufacturer: ORMCO CORP.
• Manufacturer Address: 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-03-15