MAUDE Adverse Event Report: DENTAL IMPLANT SURGERY USING 1 4.3 MM X 11.5MM NOBEL ACTIVE INTERNAL RP ON TOOTH; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Problem Insufficient Information (3190)

Patient Problem Tinnitus (2103)

Event Date 01/25/2018

Event Type  Injury  

Event Description

I had a dental implant put in by my oral surgeon on (b)(6) 2018.About a week later, i developed tinnitus.This ringing in the ear is pretty much continuous, but sometimes it is soft in volume and other times loud.

• Brand Name: DENTAL IMPLANT SURGERY USING 1 4.3 MM X 11.5MM NOBEL ACTIVE INTERNAL RP ON TOOTH
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• MDR Report Key: 7851223
• MDR Text Key: 119640511
• Report Number: MW5079650
• Device Sequence Number: 1
• Product Code: NHA
• 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: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR