• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPUTER GENERATED BRIDGE AND CROWN CROWN AND BRIDGE, TEMPORARY, RESIN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COMPUTER GENERATED BRIDGE AND CROWN CROWN AND BRIDGE, TEMPORARY, RESIN Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Sensitivity of Teeth (2427)
Event Date 08/01/2017
Event Type  Injury  
Event Description

Pt reported area of dental bridge and crown was very sensitive and caused him pain to the point that they had to take it out and replaced it with a commercial type dental bridge and crown.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOMPUTER GENERATED BRIDGE AND CROWN
Type of DeviceCROWN AND BRIDGE, TEMPORARY, RESIN
MDR Report Key7101207
MDR Text Key94408847
Report NumberMW5073858
Device Sequence Number1
Product Code EBG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/07/2017 Patient Sequence Number: 1
-
-