*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-05 for * manufactured by *.

Event Text Entries

[256007] Rptr had an initial consultation to see about getting a gap-space closed along with a series of x-rays and other procedures to determine the best option-metal braces, clear, aligners, etc. To correct the gap-spacing. Several mos later all the info was reviewed and sent back approved from invisalign. At that point rptr discussed the option to go with the aligners. After wearing the entire initial set of aligners the aligners created add'l spacing, larger gaps, more spacing. Of course, after wearing the aligners, pt was advised by the orthodontic dr that the teeth were spacing is too large, pt can not understand why that was not determined during the evaluaton process with invisalign with x-rays, pictures, etc.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026659
• MDR Report Key: 426599
• Date Received: 2002-11-05
• Date of Report: 2002-11-05
• Date of Event: 2001-01-16
• Date Added to Maude: 2002-11-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: INVISALIGN TECHNOLOGY
• Product Code: KMY
• Date Received: 2002-11-05
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: DM30494-PATIENT #-
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 415628
• Manufacturer: *
• Manufacturer Address: * SANTA CLARA CA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-11-05