MAUDE Adverse Event Report: BIOMET 3I BELLATEK® ZIRCONIA ABUTMENT

Model Number N/A

Device Problems Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

The dentist indicated that the zirconia abutment placed on (b)(6) 2013 fractured on (b)(6) 2014.The abutment was incorrectly sized (short) for the type and size of tooth to be replaced for patient's compromised bite.The crown dislodged from the abutment.The dentist reported that there was no serious patient injury, no deterioration in patient¿s health and no contributing conditions reported.

Manufacturer Narrative

This device has not yet been received for evaluation.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.

Manufacturer Narrative

Investigation results: reviewed 3shape and inspected the abutment.The abutment was inspected under the microscope and does not appear to be fractured.However, review of the abutment shows that it was slightly modified on the top of the abutment.The abutment was designed per the work order with the exception of the occlusal clearance.The customer asked for 2.5mm and it was designed at 1.6mm due to the height of the abutment being at the minimum design of (b)(4).This is the reason why the abutment is short due to the occlusal clearance requested.

• Brand Name: BELLATEK® ZIRCONIA ABUTMENT
• Type of Device: BELLATEK® 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: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766906
• MDR Report Key: 3900588
• MDR Text Key: 4426179
• Report Number: 0001038806-2014-00053
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: EDAZ
• Device Lot Number: 1160936
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1215-2014
• Patient Sequence Number: 1
• Patient Age: 66 YR