MAUDE Adverse Event Report: BIOMET 3I UNKOWN CERTAIN BELLATEK ABUTMENT; DENTAL ABUTMENT

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

Customer reported that the patient presented to the office complaining that the crown was loose.Doctor removed the abutment & crown and is currently in the process of fabricating a new crown.

Event Description

Additional information: during follow up, the doctor stated that they do not have the final abutment information or the abutment, because it was destroyed.The implant was fine and intact and since been placed with a new final abutment.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.D9: device availability was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: investigation type code was added: 4114.H6: investigation findings code was added: 3221.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.No device catalog or lot number was provided so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.Device discarded/destroyed by user.

• Brand Name: UNKOWN CERTAIN BELLATEK ABUTMENT
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11894493
• MDR Text Key: 255956428
• Report Number: 0001038806-2021-00912
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1