MAUDE Adverse Event Report: BIOMET 3I 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0; ZIRCONIA COPING

Catalog Number CBZR0600

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that the zirconia coping bridge has fractured after it was placed in the patients mouth.

Manufacturer Narrative

The reported fracture of the 3i incise zr 6 unit framework shade 0 could not be verified, product wasn't returned.There were no manufacturing deviations identified which would cause or contribute to the reported complaint.The dhr was reviewed, there were no manufacturing deviations identified which would result in or contribute to this complaint.

• Brand Name: 3I INCISE ZR 6 UNIT FRAMEWORK SHADE 0
• Type of Device: ZIRCONIA COPING
• 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: 4593226
• MDR Text Key: 15126501
• Report Number: 0001038806-2015-00431
• Device Sequence Number: 1
• Product Code: ELZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBZR0600
• Device Lot Number: 143222
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1