MAUDE Adverse Event Report: BIOMET 3I CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS; ABUTMENT

Catalog Number ICAP454

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

Event Type  malfunction  

Event Description

The lab reported a fractured abutment.The metal base had come off the abutment.

Manufacturer Narrative

Upon visual inspection, it was confirmed that the abutment has separated; the ceramic post has separated from the titanium insert.As returned, the crown remained attached to the ceramic post but the ceramic post has not fractured.The fingers of the titanium insert have not been broken; nor does the hex of the device appear damaged.In addition, it was confirmed that the clinician had used an incorrect screw.(izirts was used instead of the compatible izshg) a review of the device history records did not provide any indication of a manufacturing deviation that would contribute to this event.A definitive root cause has not been determined.

• Brand Name: CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS
• Type of Device: 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: 5202446
• MDR Text Key: 30599382
• Report Number: 0001038806-2015-00828
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK991947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ICAP454
• Device Lot Number: 1007192
• Other Device ID Number: (01)00844868004349(10)1007192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1