MAUDE Adverse Event Report: BIOMET 3I 3I INCISE ZR 3 UNIT FRAMEWORK SHADE 4; ZIRCONIA COPING

Catalog Number CBZR0304

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

The lab reported this zirconia coping fractured post restoration.

Manufacturer Narrative

Upon inspection, the complaint investigator confirmed this coping has fractured.Incise copings are designed outside of biomet3i control.Device history record and complaint history reviews did not indicate any manufacturing deviations which would cause or contribute to the reported complaint.

• Brand Name: 3I INCISE ZR 3 UNIT FRAMEWORK SHADE 4
• 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: 4820606
• MDR Text Key: 5904423
• Report Number: 0001038806-2015-00701
• Device Sequence Number: 1
• Product Code: ELZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBZR0304
• Device Lot Number: 142562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1