MAUDE Adverse Event Report: BIOMET 3I ABUTMENT, PATIENT SPECIFIC, ZIRCONIA; ZIRCONIA ABUTMENT

Catalog Number PSAZH4

Device Problems Break (1069); Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Product not returned to the manufacturer.

Event Description

The dentist reported that the patient was eating and the hex broke off the abutment.

Manufacturer Narrative

A small portion of the abutment was returned.The reported fracture was confirmed.The device history record review for the abutment was performed and did not identify any manufacturing deviations that would result in or contribute to this complaint.A definitive root cause has not been determined.Date received by manufacturer, added follow up type, added event problem codes, added evaluation codes, added device manufacture date, added device availability - date returned to manufacturer.

• Brand Name: ABUTMENT, PATIENT SPECIFIC, ZIRCONIA
• 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: 6230727
• MDR Text Key: 64494004
• Report Number: 0001038806-2017-00006
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080164
• 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: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: PSAZH4
• Device Lot Number: 62581302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1