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

Catalog Number EDAZX

Device Problems Fracture (1260); Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Product is not returned to manufacturer.

Event Description

It was reported that zirconia abutment fractured.

Manufacturer Narrative

The abutment returned was inspected and the fractured condition was confirmed.The device history record review found no non-conformances.This event is being reported due to a single preceding medical device report.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.Udi: (b)(4).Device evaluated by manufacturer: change ¿no¿ to ¿yes.¿.

• Brand Name: BELLATEK® LAB DESIGNED ZIRCONIA ABUTMENT
• 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: 6083968
• MDR Text Key: 59562562
• Report Number: 0001038806-2016-00290
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: EDAZX
• Device Lot Number: 1097828A
• Other Device ID Number: SEE NARRATIVE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1215-2014
• Patient Sequence Number: 1