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

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.

• Brand Name: COMPUTER GENERATED BRIDGE AND CROWN
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• MDR Report Key: 7101207
• MDR Text Key: 94408847
• Report Number: MW5073858
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 77