MAUDE Adverse Event Report: CEMENT USED FOR DENTAL IMPLANT; CEMENT, DENTAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Osteolysis (2377)

Event Date 08/06/2018

Event Type  Injury  

Event Description

On date above i was examined by an oral surgeon relating to inflammation at site of an existing dental implant.After dr's review or imaging, i was informed that there was bone loss, believed to have been caused by cement used to attach the crown to the abutment, at the site of two implants.Further, there is a possibility of bone loss to two add'l adjacent teeth.Is there anything i can do? i am afraid that my dental insurance might not cover the removal, restoration, and re-do.I waited for over two years for reimbursement on the last (unrelated) implant.

• Brand Name: CEMENT USED FOR DENTAL IMPLANT
• Type of Device: CEMENT, DENTAL
• MDR Report Key: 7776785
• MDR Text Key: 117129843
• Report Number: MW5079078
• Device Sequence Number: 1
• Product Code: EMA
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91