MAUDE Adverse Event Report: BIOMET 3I; ZIRCONIA ABUTMENT

Device Problems Break (1069); Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The dentist reported that zirconia abutment was sheared off at the tissue level after patient was hit in the mouth area.The dentist placed a healing abutment until the new abutment and crown are made and placed.

Manufacturer Narrative

A small portion of the unknown abutment zirconia was returned.The reported fracture was confirmed.The part and lot numbers were not provided; therefore, the risk management files could not be reviewed.A definite cause could not be determined.This event is being reported due to a single preceding medical device report where surgical intervention did occur.This event is a subsequent malfunction.The risk to the patient is remote.Investigation of other complaints with similar abutments that were fractured concluded the fracture was related to the design of the hex and boss connection and to the screw access hole which led to the recall.Date received by manufacturer, add follow up type, device evaluated by manufacturer: change ¿no¿ to ¿yes¿, add event problem codes, add evaluation codes.

• Type of Device: ZIRCONIA ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6171067
• MDR Text Key: 62614312
• Report Number: 0001038806-2016-00337
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1