PARADIGM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-09 for PARADIGM * manufactured by 3m.

Event Text Entries

[15603999] I recently received an advertising piece from 3m promoting their paradigm restorative blocks for the cerec cad/cam system. Please note that paradigm is promoted for use in cases involving bruxers and heavy occlusion. (bruxism is the highly destructive process of clenching one's teeth. The package insert for this product states, "paradigm mz100 block is not recommended for bruxers or clenchers. " this is a highly important contradiction. When i called 3m for clarification, the customer svc rep said. "oh, we must have forgotten to change the package insert. " if there is a conflict between a marketing campaign and the package insert, it would seem to me that simply changing the technical data to match the marketing strategy is not appropriate. Since this affects pts, it also would seem to me to be reckless and irresponsible. In my 3 yrs of experience with the cerec system, i have learned to be very skeptical of all of the corps involved with the technology and their glib claims. Having little hope receiving an answer based on scientific evidence, i am asking you to look into this.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039052
• MDR Report Key: 722080
• Date Received: 2006-05-09
• Date Added to Maude: 2006-06-06
• 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: 3
• Reporter Occupation: DENTIST
• 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: PARADIGM
• Generic Name: *
• Product Code: NSP
• Date Received: 2006-05-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 711146
• Manufacturer: 3M
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-05-09