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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRM RESEARCH LABORATORIES, INC. DIAMOND CROWN

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DRM RESEARCH LABORATORIES, INC. DIAMOND CROWN Back to Search Results
Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem Failure to Anastomose (1028)
Event Date 01/01/2010
Event Type  Injury  
Event Description

Pt received 19 dental crowns made from a light-cured composite material known as "diamond crown", manufactured by drm research laboratories, inc. The "diamond crown" crowns were placed on pt's natural teeth in 2006. The only product which this manufacturer has approved by the fda is a metal implant product (b)(4). The "diamond crown" material has failed crowns leaking and pt now requires crowns be replaced. Manufacturer is marketing "diamond crown" product as being suitable for use as crown material on natural teeth, but the only product fda has approved from this manufacturer is a metal implant (b)(4). Lawsuit has been filed against manufacturer for defective product. In lawsuit, manufacturer claims "diamond crown" has been approved for use on natural teeth, citing letter from fda dated (b)(6) 2004. However, said letter relates only to metal implant product - (b)(4) -. Diagnosis or reason for use: stop decay of natural teeth - restoration of natural teeth.

 
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Brand NameDIAMOND CROWN
Type of DeviceDIAMOND CROWN
Manufacturer (Section D)
DRM RESEARCH LABORATORIES, INC.
branford CT
MDR Report Key2003216
MDR Text Key16582145
Report NumberMW5019496
Device Sequence Number1
Product Code DZE
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 02/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 02/21/2011 Patient Sequence Number: 1
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